CONTIGEN BARD COLLAGEN IMPLANT
FDA premarket approval P900030/S009 · decided 2006-09-21
Approval details
- PMA number
- P900030
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- 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
- 2005-06-13
- Decision date
- 2006-09-21
- Days to decision
- 465 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 INCLUDE INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT B.
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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 |