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 (PREMIXED) |
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 | S004 |
Date Received | 04/05/2006 |
Decision Date | 05/11/2007 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE COSEAL SPRAY DELIVERY SYSTEM WITH A SPRAY SET AND PRESSURE REGULATOR. |
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