| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | RX ACCULINK CAROTID STENT SYSTEM |
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| Generic Name | Stent, carotid |
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| Applicant | Abbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054 |
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| PMA Number | P040012 |
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| Supplement Number | S027 |
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| Date Received | 09/27/2007 |
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| Decision Date | 02/21/2008 |
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| Product Code |
NIM |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Labeling Change - PAS |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR MODIFICATIONS OF THE DEVICE LABELING TO INCLUDE AN ADDITIONAL WARNING AND A SUMMARY OF THE CAPTURE POST-APPROVAL STUDY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RX ACCUYLINK CAROTID STENT SYSTEM AND, USED IN CONJUNCTION WITH ABBOTT VASCULAR X ACCUNET EMBOLIC PROTECTION SYSTEMS, IS INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE REVASCULARIZATION AND MEET THE FOLLOWING CRITERIA: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITH OUT NEUROLOGICAL SYMPTOMS AND >= 80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION. |
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