PMA P040021S011

Device: SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S011
Product code: LWR
Decision date: 2009-10-02
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, WOODRIDGE FACILITY, ST. PAUL, MINNESOTA FOR BIOBURDEN REDUCTION AND CHEMICAL FIXATION OF THE BIOCOR AND EPIC FAMILY OF HEART VALVES.

Current openFDA PMA Record#

Device: SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S011
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2009-10-02
Decision code: APPR
Date received: 2009-08-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, WOODRIDGE FACILITY, ST. PAUL, MINNESOTA FOR BIOBURDEN REDUCTION AND CHEMICAL FIXATION OF THE BIOCOR AND EPIC FAMILY OF HEART VALVES.