INTRA COIL SELF-EXPANDING PERIPHERAL STENT
FDA premarket approval P000033 · decided 2002-04-03
Approval details
- PMA number
- P000033
- Trade name
- INTRA COIL SELF-EXPANDING PERIPHERAL STENT
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2000-08-03
- Decision date
- 2002-04-03
- Days to decision
- 608 days
- Decision code
- APWD
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE INTRACOIL SELF-EXPANDING PERIPHERAL STENT. THIS DEVICE IS INDICATED FOR IMPROVING PERIPHERAL LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE DUE TO STENOTIC LESIONS (LENGTH <= 15 CM) OR OCCLUSIVE LESIONS (LENGTH <= 12 CM) IN FEMOROPOPLITEAL ARTERIES, TO THE BIFURCATION OF THE TIBIAL ARTERY, WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 7.8 MM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| 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 |