ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
FDA premarket approval P050025 · decided 2006-10-27
Approval details
- PMA number
- P050025
- Trade name
- ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific
- Date received
- 2005-07-15
- Decision date
- 2006-10-27
- Days to decision
- 469 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE ENDOTEX NEXSTENT. THIS DEVICE IS INDICATED FOR TREATMENT OF 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 ARTERY BY DUPLEX ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND 2) PATIENTS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.