PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM
FDA premarket approval P060001/S020 · decided 2015-01-21
Approval details
- PMA number
- P060001
- Supplement
- S020
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2014-05-02
- Decision date
- 2015-01-21
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO AND INCLUDING 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF7.5 TO 11 MM.
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