TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
FDA premarket approval P960043/S009 · decided 1999-05-05
Approval details
- PMA number
- P960043
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-07-21
- Decision date
- 1999-05-05
- Days to decision
- 288 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for additional effectiveness claims (i.e., reduced time to ambulation and reduced time to discharge) for the Techstar(R) XL 6 Fr. Percutaneous Vascular Surgical (PVS) System. The device will be marketed under the trade name Techstar XL 6F Percutaneous Vascular Surgical (PVS) System and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to ambulation (patient walks ten feet) of patients who have undergone di
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