PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
FDA premarket approval P960043/S014 · decided 1998-12-21
Approval details
- PMA number
- P960043
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-11-16
- Decision date
- 1998-12-21
- Days to decision
- 35 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for adding precautions to the Clinical Procedure section of the Instructions for Use regarding suture lumen clamping.
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 |