PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM
FDA premarket approval P960043/S005 · decided 1998-09-02
Approval details
- PMA number
- P960043
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-03-09
- Decision date
- 1998-09-02
- Days to decision
- 177 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for a modified Percutaneous Vascular Surgical (PVS) System. The device, as modified, will be marketed under the trade name Prostar(R) XL 10 French Percutaneous Vascular Surgical (PVS) System and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths.
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