PMA P020024S041

Device: AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S041
Product code: MAE
Decision date: 2016-04-29
Classification: Occluder, Patent Ductus, Arteriosus
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Approval order statement: Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.

Current openFDA PMA Record#

Device: AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S041
Product code: MAE
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Decision date: 2016-04-29
Decision code: APPR
Date received: 2015-08-21
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, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.