PMA P900030

Device: CONTIGEN BARD COLLAGEN IMPLANT
Applicant: Allergan, Inc.
PMA number: P900030
Supplement: S011
Product code: LNM
Decision date: 2009-10-02
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDES INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTIGEN BARD COLLAGEN IMPLANT AND IS INDICATED FOR USE ONLY IN THE TREATMENT OF URINARY INCONTINENCE DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD, POOR OR NONFUNCTIONING BLADDER OUTLET MECHANISM) THAT MAY BE HELPED BY A LOCALLY INJECTED BULKING AGENT. CONTIGEN IMPLANT THERAPY SHOULD BE INITIATED ONLY IN PATIENTS WHO HAVE SHOWN NO IMPROVEMENT IN THEIR INCONTINENCE FOR AT LEAST 12 MONTHS.

Current openFDA PMA Record#

Device: CONTIGEN BARD COLLAGEN IMPLANT
Applicant: Allergan, Inc.
PMA number: P900030
Supplement: S011
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2009-10-02
Decision code: APPR
Date received: 2009-03-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDES INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTIGEN BARD COLLAGEN IMPLANT AND IS INDICATED FOR USE ONLY IN THE TREATMENT OF URINARY INCONTINENCE DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD, POOR OR NONFUNCTIONING BLADDER OUTLET MECHANISM) THAT MAY BE HELPED BY A LOCALLY INJECTED BULKING AGENT. CONTIGEN IMPLANT THERAPY SHOULD BE INITIATED ONLY IN PATIENTS WHO HAVE SHOWN NO IMPROVEMENT IN THEIR INCONTINENCE FOR AT LEAST 12 MONTHS.