RX ACCULINK CAROTID STENT SYSTEM
FDA premarket approval P040012/S031 · decided 2010-04-30
Approval details
- PMA number
- P040012
- Supplement
- S031
- Supplement type
- Normal 180 Day 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
- 2009-11-02
- Decision date
- 2010-04-30
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INDICATION STATEMENT AND INSTRUCTIONS FOR USE TO INCORPORATE USE WITH THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM. THE DEVICE, AS MODIFIED, WILLBE MARKETED UNDER THE TRADE NAME RX ACCULINK CAROTID STEM SYSTEM AND IS INDICATED FOR USEIN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTIONSYSTEMS, FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET TH
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510(k) clearances by this applicant
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