ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
FDA premarket approval P150023/S001 · decided 2016-10-07
Approval details
- PMA number
- P150023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
- Generic name
- Absorbable coronary drug-eluting stent
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2016-07-11
- Decision date
- 2016-10-07
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- PNY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |