Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S021 |
Date Received | 06/19/2015 |
Decision Date | 07/21/2015 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement EXPAND THE EXISTING CLEAN MANUFACTURING ENVIRONMENT (CME) AREA IN YOUR SAN LORENZO MANUFACTURING FACILITY. IN ADDITION, THE 30-DAY NOTICE REQUESTED TO ADD A SECOND DEHUMIDIFICATION CHAMBER AS WELL AS ADD TWO ADDITIONAL FILLING BANKS (TO TOTAL FOUR FILLING STATIONS) INTO THIS NEW AREA. |
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