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 | COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P810006 |
Supplement Number | S072 |
Date Received | 05/25/2016 |
Decision Date | 06/22/2016 |
Product Code |
LMF |
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 Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packaging of ACS Sponge 3”x 4” or 1”x 2” 6-Pack or 1”x 2” 2-Packs on the Belco Sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging. |
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