PMA P150023S007

Device: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System.
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S007
Product code: PNY
Decision date: 2017-08-07
Classification: Absorbable Coronary Drug-eluting Stent
Generic name: Absorbable coronary drug-eluting stent
Approval order statement: Approval to change the finished goods molecular weight testing sampling plan and molecular weight stability testing plan.

Current openFDA PMA Record#

Device: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System.
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S007
Product code: PNY
Generic name: Absorbable coronary drug-eluting stent
Decision date: 2017-08-07
Decision code: APPR
Date received: 2017-03-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to change the finished goods molecular weight testing sampling plan and molecular weight stability testing plan.