PMA P990028S002

Device: FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
Applicant: Genzyme Corp.
PMA number: P990028
Supplement: S002
Product code: FTL
Decision date: 2001-07-16
Classification: Mesh, Surgical, Polymeric
Generic name: Mesh, surgical, polymeric
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.

Current openFDA PMA Record#

Device: FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
Applicant: Genzyme Corp.
PMA number: P990028
Supplement: S002
Product code: FTL
Generic name: Mesh, surgical, polymeric
Decision date: 2001-07-16
Decision code: APPR
Date received: 2001-01-09
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.