RX ACCULINK CAROTID STENT SYSTEM
FDA premarket approval P040012/S034 · decided 2011-05-06
Approval details
- PMA number
- P040012
- Supplement
- S034
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RX ACCULINK CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2010-10-01
- Decision date
- 2011-05-06
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE RX ACCULINK CAROTID STENT SYSTEM. THE DEVICE IS INDICATED FOR HIGH SURGICAL RISK AND STANDARD SURGICAL RISK PATIENTS AS FOLLOWS: HIGH SURGICAL RISK -THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS), IS INDICATED FOR THE TREATMENT OF 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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510(k) clearances by this applicant
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