Medical Devices

File Description for the CDRH Releasable (Approved) PMAs

Data Format Updated: April 28, 2010

Each data element is separated by a | pipe symbol. The position of the element represents where it appears in the piped line, IE,

position1|position2|position3|position4|etc.

(Previous releases of this data were in fixed width format with an X at the end; this is no longer the case.)

PositionDescription
1PMA Number
2Supplement Number
3Applicant
4Street_1
5Street_2
6City
7State
8Zip
9Zip_Ext
10Generic Name
11Trade Name
12Product Code
13Advisory Committee
14Type of Supplement
15Primary Reason for Supplement
16Expedited Review Granted (Y/N)
17Date Received (mm-dd-yyyy)
18Date Decision (mm-dd-yyyy)
19Docket Number
20Date of Federal Register Notice (mm-dd-yyyy)
21Decision Code
22Approval Order Statement

Type of Supplement

THIRTY DAY TRACK
PANEL TRACK
SPECIAL(IMMEDIATE TRACK)
REAL-TIME PROCESS
30-DAY NOTIFICATION
135 REVIEW TRACK FOR 30-DAY NOTIFICATION


Primary Reason for Supplement

CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COLOR ADDITIVE
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS
CHANGE IN LOCATION PILOT
DESIGN CHANGE - MINOR
LABELING CHANGE - INDICATIONS
LABELING CHANGE - INSTRUCTIONS
LABELING CHANGE - MINOR
LABELING CHANGE - OTHER
LABELING CHANGE - PERFORMANCE CHARACTERISTICS
LABELING CHANGE - SHELF-LIFE
LABELING CHANGE - TRADE NAME
LOCATION CHANGE - OTHER
LOCATION CHANGE: DISTRIBUTOR
LOCATION CHANGE: MANUFACTURER
LOCATION CHANGE: PACKAGER
LOCATION CHANGE: STERILIZER
POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL
PROCESS CHANGE - OTHER
PROCESS CHANGE: MANUFACTURING
PROCESS CHANGE: PACKAGING
PROCESS CHANGE: STERILIZATION
OTHER

Page Last Updated: 02/11/2015
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