PMA P990028

Device: FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
Applicant: Genzyme Corp.
PMA number: P990028
Supplement: S007
Product code: FTL
Decision date: 2003-12-04
Classification: Mesh, Surgical, Polymeric
Generic name: Mesh, surgical, polymeric
Approval order statement: APPROVAL FOR COMPLAINT RETURN AND INVESTIGATION OPERATIONS TO BE TRANSFERRED FROM THE GENZYME FACILITY IN LEXINGTON, MASSACHUSETTS TO THE GENZYME FACILITY IN FARMINGHAM, MASSACHUSETTS.

Current openFDA PMA Record#

Device: FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
Applicant: Genzyme Corp.
PMA number: P990028
Supplement: S007
Product code: FTL
Generic name: Mesh, surgical, polymeric
Decision date: 2003-12-04
Decision code: APPR
Date received: 2003-11-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR COMPLAINT RETURN AND INVESTIGATION OPERATIONS TO BE TRANSFERRED FROM THE GENZYME FACILITY IN LEXINGTON, MASSACHUSETTS TO THE GENZYME FACILITY IN FARMINGHAM, MASSACHUSETTS.