CONTIGEN BARD COLLAGEN IMPLANT
FDA premarket approval P900030/S010 · decided 2008-01-11
Approval details
- PMA number
- P900030
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONTIGEN BARD COLLAGEN IMPLANT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Allergan, Inc.
- Date received
- 2007-12-18
- Decision date
- 2008-01-11
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Goleta, CA
- Statement
- APPROVAL FOR UPDATED DIRECTIONS FOR USE IN ORDER TO STRENGTHEN INFORMATION ON ADVERSE EVENTS.
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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 |