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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.)

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

 
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