TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
FDA premarket approval P960043/S001 · decided 1997-11-05
Approval details
- PMA number
- P960043
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1997-05-01
- Decision date
- 1997-11-05
- Days to decision
- 188 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for modified Percutaneous Vascular Surgical devices. The devices, as modified, will be marketed under the trade names Techstar(TM) 6 French Percutaneous Vascular Surgical (PVS) System and Techstar(TM) XL 6 French PVS System and are indicated for the percutaneous delivery of sutures for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 French sheaths.
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