TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
FDA premarket approval P960043/S008 · decided 1998-07-17
Approval details
- PMA number
- P960043
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-06-22
- Decision date
- 1998-07-17
- Days to decision
- 25 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for revised labeling and training materials including, the PVS Guidelines for post-procedural care and the training video entitled PVS Post Procedure Care.
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| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
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| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
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| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |