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 | SEPRAFILM |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S036 |
Date Received | 10/08/2010 |
Decision Date | 12/02/2010 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPGRADES MADE IN MANUFACTURING AREAS AND EQUIPMENT. |
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