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 | COSEAL SURGICAL SEALANT |
Generic Name | Sealant, polymerizing |
Applicant | BAXTER BIO SCIENCE 32650 N WILSON RD MAIL STOP WG2-3S ROUND LAKE, IL 60073 |
PMA Number | P030039 |
Supplement Number | S016 |
Date Received | 06/01/2010 |
Decision Date | 07/01/2010 |
Product Code |
NBE |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDING A LOT RELEASE SURVEILLANCE SAMPLE TEST FOR FUNCTIONALITY. |
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