ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
FDA premarket approval P150023 · decided 2016-07-05
Approval details
- PMA number
- P150023
- Trade name
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
- Generic name
- Absorbable coronary drug-eluting stent
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2015-07-01
- Decision date
- 2016-07-05
- Days to decision
- 370 days
- Decision code
- APWD
- Product code
- PNY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length.
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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 |