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Dockets Management

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Food and Drug Administration

Obstetrics and Gynecology Devices Panel

December 14, 2007

BRIEFING INFORMATION

Cytyc

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Cytyc Surgical Products Panel Pack:

Adiana Transcervical Sterilization System PMA P070022 Panel Package - Pgs. 1-100, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 101-200, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 201-300, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 301-400, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 401-500, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Pre-market Application; Adiana Transcervical Sterilization System, Panel Package - Pgs. 501-600, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 601-700, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 701-800, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 801-900, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 901-1000, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package – Pgs. 1001-1100, OB-GYN, December 14, 2007 (pdf)

Adiana, Inc. Premarket Application; Adiana Transcervical Sterilization System, Panel Package Pgs. 1101-1136, OB-GYN, December 14, 2007 (pdf)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

Executive Summary (pdf)


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