CONTIGEN BARD COLLAGEN IMPLANT
FDA premarket approval P900030/S011 · decided 2009-10-02
Approval details
- PMA number
- P900030
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CONTIGEN BARD COLLAGEN IMPLANT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Allergan, Inc.
- Date received
- 2009-03-03
- Decision date
- 2009-10-02
- Days to decision
- 213 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Goleta, CA
- 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 S
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| REFRESH RELIEVA For CONTACTS (K190674) | Allergan, Inc. | 2019-08-08 |
| XEN Glaucoma Treatment System (K161457) | Allergan, Inc. | 2016-11-21 |
| Natrelle 133 Plus Tissue Expander (K143354) | Allergan, Inc. | 2015-08-20 |
| REFRESH OPTIVE LENS COMFORT REWETTING DROPS (K083812) | Allergan, Inc. | 2009-07-09 |
| SINGLE AMPLIFIER FOR BOTOX (K051852) | Allergan, Inc. | 2005-09-14 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION (K014202) | Allergan, Inc. | 2002-02-20 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION (K013479) | Allergan, Inc. | 2002-02-11 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION (K003252) | Allergan, Inc. | 2001-02-21 |