PROTEGE RX CAROTID STENT SYSTEM
FDA premarket approval P060001/S017 · decided 2013-02-12
Approval details
- PMA number
- P060001
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- PROTEGE RX CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2012-08-21
- Decision date
- 2013-02-12
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE CREATE POST- APPROVAL STUDY (PAS) RESULTS TO THE INSTRUCTIONS FOR USE (IFU).
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|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
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| 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 |