PMA P040012S005

Device: RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S005
Product code: NIM
Decision date: 2006-03-24
Generic name: Stent, carotid
Approval order statement: CHANGES IMPLEMENTED TO THE PACKAGING MANUFACTURING PROCESS INSTRUCTION (MPI2027943, POUCH/HEADER BAG PACKAGING PROCEDURE). CHANGES PERTAIN TO THE MANUFACTURING INSPECTION OF POUCH/POUCH SEAL.

Current openFDA PMA Record#

Device: RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S005
Product code: NIM
Generic name: Stent, carotid
Decision date: 2006-03-24
Decision code: OK30
Date received: 2006-02-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES IMPLEMENTED TO THE PACKAGING MANUFACTURING PROCESS INSTRUCTION (MPI2027943, POUCH/HEADER BAG PACKAGING PROCEDURE). CHANGES PERTAIN TO THE MANUFACTURING INSPECTION OF POUCH/POUCH SEAL.