PMA P150023S003
- Device
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P150023
- Supplement
- S003
- Product code
- PNY
- Decision date
- 2017-10-10
- Classification
- Absorbable Coronary Drug-eluting Stent
- Generic name
- Absorbable coronary drug-eluting stent
- Approval order statement
- Approval for your premarket approval application (PMA) request that we place your study on hold.
Current openFDA PMA Record#
- Device
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P150023
- Supplement
- S003
- Product code
- PNY
- Generic name
- Absorbable coronary drug-eluting stent
- Decision date
- 2017-10-10
- Decision code
- APPR
- Date received
- 2016-08-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for your premarket approval application (PMA) request that we place your study on hold.