PMA P040012S009

Device: RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S009
Product code: NIM
Decision date: 2006-07-18
Generic name: Stent, carotid
Approval order statement: APPROVAL FOR A MODIFICATION TO A MANUFACTURING PROCESS TO IMPROVE WICKING OF GLUE BETWEEN THE HYPOTUBE AND THE INNER MEMBER AND A MODIFICATION TO THE LOT HISTORY RECORD BILL OF MATERIALS TO ADD A NEW BLOCK FOR DOCUMENTING THE NEW PROCESS.

Current openFDA PMA Record#

Device: RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S009
Product code: NIM
Generic name: Stent, carotid
Decision date: 2006-07-18
Decision code: APPR
Date received: 2006-02-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MODIFICATION TO A MANUFACTURING PROCESS TO IMPROVE WICKING OF GLUE BETWEEN THE HYPOTUBE AND THE INNER MEMBER AND A MODIFICATION TO THE LOT HISTORY RECORD BILL OF MATERIALS TO ADD A NEW BLOCK FOR DOCUMENTING THE NEW PROCESS.