|
Device | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT |
Generic Name | Mesh, surgical, polymeric |
Regulation Number | 878.3300 |
Applicant | GENZYME CORP. 55 CAMBRIDGE PARKWAY CAMBRIDGE, MA 02142 |
PMA Number | P990028 |
Supplement Number | S002 |
Date Received | 01/09/2001 |
Decision Date | 07/16/2001 |
Withdrawal Date
|
02/10/2016 |
Product Code |
FTL |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT CHESAPEAKE BIOLOGICAL LABORATORIES, INC., BALTIMORE, MD. THE FACILITY WILL PERFORM THE ASEPTIC FORMULATION AND FILLING OF PRIMER VIAL 2 OF FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT. |