PMA P040012S010

Device: RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S010
Product code: NIM
Decision date: 2006-03-14
Generic name: Stent, carotid
Approval order statement: APPROVAL FOR REMOVAL OF STENT MASS AS A FINAL PRODUCT SPECIFICATION FOR THE RX ACCULINK CAROTID STENT SYSTEM AND MODIFICATION OF THE SPECIFICATIONS REGARDING ALLOWABLE CONTAMINANT IN THE DEVICE PACKAGING.

Current openFDA PMA Record#

Device: RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S010
Product code: NIM
Generic name: Stent, carotid
Decision date: 2006-03-14
Decision code: APPR
Date received: 2006-02-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR REMOVAL OF STENT MASS AS A FINAL PRODUCT SPECIFICATION FOR THE RX ACCULINK CAROTID STENT SYSTEM AND MODIFICATION OF THE SPECIFICATIONS REGARDING ALLOWABLE CONTAMINANT IN THE DEVICE PACKAGING.