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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 |
Date Received | 07/16/2003 |
Decision Date | 12/12/2003 |
Product Code |
NBE |
Docket Number | 03M-0560 |
Notice Date | 12/31/2003 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR REFERENCE RIGHTS TO P010022. THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 |