|
Device | COSEAL SURGICAL SEALANT (COSEAL) |
Generic Name | Sealant, polymerizing |
Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.W 47TH AVENUE GAINESVILLE, FL 32608 |
PMA Number | P010022 |
Date Received | 04/12/2001 |
Decision Date | 12/14/2001 |
Withdrawal Date
|
03/15/2012 |
Product Code |
NBE |
Docket Number | 02M-0076 |
Notice Date | 02/25/2002 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE COSEAL SURGICAL SEALANT. THIS 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
|
Supplements: |
S001 S002 S003 |