EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
FDA premarket approval P070012 · decided 2007-10-23
Approval details
- PMA number
- P070012
- Trade name
- EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular
- Date received
- 2007-04-30
- Decision date
- 2007-10-23
- Days to decision
- 176 days
- Decision code
- APWD
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM. THE DEVICE IS INDICATED FOR USE, IN CONJUNCTION WITH A MEDTRONIC VASCULAR EMBOLIC PROTECTION SYSTEM, FOR IMPROVING CAROTID LUMINAL DIAMETER IN PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTE
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