PMA P150023S001

Device: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S001
Product code: PNY
Decision date: 2016-10-07
Classification: Absorbable Coronary Drug-eluting Stent
Generic name: Absorbable coronary drug-eluting stent
Approval order statement: Approval for a shelf life extension from 12 months to 18 months for the small scaffold design (2.5 and 3.0mm diameters), and the implementation of an alternate temperature monitoring system.

Current openFDA PMA Record#

Device: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S001
Product code: PNY
Generic name: Absorbable coronary drug-eluting stent
Decision date: 2016-10-07
Decision code: APPR
Date received: 2016-07-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a shelf life extension from 12 months to 18 months for the small scaffold design (2.5 and 3.0mm diameters), and the implementation of an alternate temperature monitoring system.