PMA P040012S003

Device: ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S003
Product code: NIM
Decision date: 2006-03-16
Generic name: Stent, carotid
Approval order statement: APPROVAL OF MODIFICATIONS TO THE PROTOCOL FOR THE ARCHER LONG TERM FOLLOW-UP (LTFU) TRIAL. THE REVISED PROTOCOL INCLUDES MEASURES DESIGNED TO ASSIST IN THE RECRUITMENT AND EVALUATION OF PATIENTS, AND COMPLIES WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 30, 2004 APPROVAL ORDER FOR P040012.

Current openFDA PMA Record#

Device: ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S003
Product code: NIM
Generic name: Stent, carotid
Decision date: 2006-03-16
Decision code: APPR
Date received: 2005-12-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: APPROVAL OF MODIFICATIONS TO THE PROTOCOL FOR THE ARCHER LONG TERM FOLLOW-UP (LTFU) TRIAL. THE REVISED PROTOCOL INCLUDES MEASURES DESIGNED TO ASSIST IN THE RECRUITMENT AND EVALUATION OF PATIENTS, AND COMPLIES WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 30, 2004 APPROVAL ORDER FOR P040012.