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 ADHESION BARRIER/SEPRAFILM PROCEDURE PACK |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S018 |
Date Received | 08/20/2001 |
Decision Date | 10/04/2001 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE PRODUCT RELEASE FACILITY AT GENZYME SURGICAL PRODUCTS, FALL RIVER, MASSACHUSETTS. |
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