PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEM
FDA premarket approval P960043/S007 · decided 1999-05-05
Approval details
- PMA number
- P960043
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEM
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-04-15
- Decision date
- 1999-05-05
- Days to decision
- 385 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for an additional effectiveness claim (i.e., reduced time to discharge) for the Prostar(R) XL 8F Percutaneous Vascular Surgical (PVS) System. The device will be marketed under the trade name Prostar(R) XL 8F 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 time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterizatio
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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 |