PMA P020024S057

Device: AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S057
Product code: MAE
Decision date: 2019-08-22
Classification: Occluder, Patent Ductus, Arteriosus
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Approval order statement: Approval for an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.

Current openFDA PMA Record#

Device: AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S057
Product code: MAE
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Decision date: 2019-08-22
Decision code: APPR
Date received: 2019-06-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.