RX ACCULINK CAROTID STENT SYSTEM

FDA premarket approval P040012/S027 · decided 2008-02-21

Approval details

PMA number

P040012

Supplement

S027

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Labeling Change - PAS

Trade name

RX ACCULINK CAROTID STENT SYSTEM

Generic name

Stent, carotid

Applicant

Abbott Vascular

Date received

2007-09-27

Decision date

2008-02-21

Days to decision

147 days

Decision code

APPR

Product code

NIM

Advisory committee

Cardiovascular

Expedited review

No

Location

Santa Clara, CA

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 NEU

510(k) clearances by this applicant