PMA P150023S002

Device: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S002
Product code: PNY
Decision date: 2016-08-25
Classification: Absorbable Coronary Drug-eluting Stent
Generic name: Absorbable coronary drug-eluting stent
Approval order statement: Approval for labeling changes to clarify the interpretation of the ABSORB III clinical data for geriatric patients in the Absorb GT1 BVS Instructions for Use.

Current openFDA PMA Record#

Device: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P150023
Supplement: S002
Product code: PNY
Generic name: Absorbable coronary drug-eluting stent
Decision date: 2016-08-25
Decision code: APPR
Date received: 2016-07-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to clarify the interpretation of the ABSORB III clinical data for geriatric patients in the Absorb GT1 BVS Instructions for Use.