PMA P900030S005

Device: CONTIGEN BARD COLLAGEN IMPLANT
Applicant: Allergan, Inc.
PMA number: P900030
Supplement: S005
Product code: LNM
Decision date: 1996-03-08
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: APPROVAL FOR:1) MARKETINGTHE CURRENT CONTIGEN IMPLANT PRODUCT LINE IN A MODIFIED PACKAGING CONFIGURATION INSTEAD OF THE CURRENT CONFIGURATION, 2)CHANGING THE LOCATION OF THE SKINT TEST PACKAGING OPERATIN FROM COLLAGEN CORP, FREMONT, CA, TO BARD UROLOGICAL DIV, COVINGTON, GA 3)REVISING THE WARNING STATEMENT REGARDING CONNECTIVE TISSUE DISEASE IN THE PACKAGE INSERTS, PATIENT BROCHURES AND SAFETY SUMMARIES, AND 4)UPDATING THE PATIENT RECORD AND SKIN TEST CARD LABELING

Current openFDA PMA Record#

Device: CONTIGEN BARD COLLAGEN IMPLANT
Applicant: Allergan, Inc.
PMA number: P900030
Supplement: S005
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 1996-03-08
Decision code: APPR
Date received: 1995-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR:1) MARKETINGTHE CURRENT CONTIGEN IMPLANT PRODUCT LINE IN A MODIFIED PACKAGING CONFIGURATION INSTEAD OF THE CURRENT CONFIGURATION, 2)CHANGING THE LOCATION OF THE SKINT TEST PACKAGING OPERATIN FROM COLLAGEN CORP, FREMONT, CA, TO BARD UROLOGICAL DIV, COVINGTON, GA 3)REVISING THE WARNING STATEMENT REGARDING CONNECTIVE TISSUE DISEASE IN THE PACKAGE INSERTS, PATIENT BROCHURES AND SAFETY SUMMARIES, AND 4)UPDATING THE PATIENT RECORD AND SKIN TEST CARD LABELING