|
Device | COSEAL SURGICAL SEALANT DEVICE |
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 | S013 |
Date Received | 03/17/2009 |
Decision Date | 09/03/2009 |
Product Code |
NBE |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW SUPPLIER OF PEG COMPONENT MATERIAL. |