PMA P150023S005

Device: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S005
Product code: PNY
Decision date: 2016-10-07
Classification: Absorbable Coronary Drug-eluting Stent
Generic name: Absorbable coronary drug-eluting stent
Approval order statement: Update transportation methods to and from the contract sterilizer and to update the configuration for sterilization processing at the contract sterilizer.

Current openFDA PMA Record#

Device: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S005
Product code: PNY
Generic name: Absorbable coronary drug-eluting stent
Decision date: 2016-10-07
Decision code: OK30
Date received: 2016-09-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update transportation methods to and from the contract sterilizer and to update the configuration for sterilization processing at the contract sterilizer.