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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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M.I. Tech Co Ltd 7/29/10

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 Warning Letter



Via United Parcel Service


JUL 29, 2010


Gim Chul Soo
President and CEO
M.I. Tech Co., Ltd
241-3 Habukri Jinwimyeon
Pyeongtaek,
Republic of Korea
451864

RE: Choostent Esophagus Asymetric (CCC)
Choostent Esophagus (CCC)
Choostent Esophagus (NCN)
Choostent Esophagus Upper (CCC)
Choostcnt Esophagus ST (CCN)
Choostent Esophagus Valve (CCC)
Choostent Esophagus Valve (CCN)
Choostent Colon/Rectum (CCC)
Choostent Colon/Rectum Asymmetric (CCC)
Hanarostent Esophagus Benign BS (CCC)
Hanarostent Esophagus Valve BS (CCC)
Hanarostent Biliary (NNN)
Hanarostent Biliary (CCC)
Hanarostent Biliary Lasso (CCC)
Hanarostent Biliary Hilar (NNN)
Hanarostent Duodenum/Pylorus (NNN)
Hanarostent Duodenum/Pylorus (NCN)
Hanarostent Intestine (CCC)
Hanarostent Colon/Rectum (NNN)
Hanarostent Colon/Rectum Asymetric (CCC)
Hanarostent Trachea/Bronchium (CCC)

Dear Mr. Gim:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Choostent Esophagus Asyrrietric (CCC), Choostent Esophagus (CCC), Choostent Esophagus (NCN), Choostent Esophagus Upper (CCC), Choostent Esophagus ST (CCN), Choostent Esophagus Valve (CCC), Choostent Esophagus Valve (CCN), Choostent Colon/Rectum (CCC), Choostent Colon/Rectum Asymmetric (CCC), Hanarostent Esophagus Benign BS (CCC), Hanarostent Esophagus Valve BS (CCC), Hanarostent Biliary (NNN), Hanarostent Biliary (CCC), Hanarostent Biliary Lasso (CCC), Hanarostent Biliary Hilar (NNN), Hanarostent Duodenum/Pylorus (NNN), Hanarostent Duodenum/Pylorus (NCN), Hanarostent Intestine (CCC), Hanarostent Colon/Rectum (NNN), Hanarostent Colon/Rectum Asymetric (CCC), and Hanarostent Trachea/Bronchium (CCC) [Choostents and Hanarostents] in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed promotional material you distributed at Digestive Diseases Week (DDW) 2010, from May 1-5, 2010, in New Orleans and internet websites for the above mentioned Choostents and Hamostents. These products are devices within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act. The Act requires that manufacturers of devices that are not exempt obtain marketing clearance or approval for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country.

These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IED) under section 520(g) of the Act, 21 U.S.C. 360j(g). These devices are also misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).

You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request and listing all promotional materials for the above mentioned Choostents and Hanarostents the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Paul Tilton at the Food and Drug Administration, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66-3520, Silver Spring, Maryland 20993-0002, facsimile at (301) 847-8137.We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that the above mentioned Choostents and Hanarostents comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely yours,

/s/

Tinothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health


cc:
Brandon Choi
US Agent:
PATS CORP
49 Candlewood Way
Buena Park, CA 90621