PMA P040012S027

Device: RX ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S027
Product code: NIM
Decision date: 2008-02-21
Generic name: Stent, carotid
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.

Current openFDA PMA Record#

Device: RX ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S027
Product code: NIM
Generic name: Stent, carotid
Decision date: 2008-02-21
Decision code: APPR
Date received: 2007-09-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
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.