PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
FDA premarket approval P060001 · decided 2007-01-24
Approval details
- PMA number
- P060001
- Trade name
- PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2006-01-09
- Decision date
- 2007-01-24
- Days to decision
- 380 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USED IN CONJUNCTION WITH EV3 EMBOLIC PROTECTION DEVICES, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID REVASCULARIZATION AND MEET THE FOLLOWING CRITERIA:1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGI
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510(k) clearances by this applicant
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|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
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| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |