CONTIGEN BARD COLLAGEN IMPLANT
FDA premarket approval P900030/S005 · decided 1996-03-08
Approval details
- PMA number
- P900030
- Supplement
- S005
- Supplement type
- Normal 180 Day 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
- 1995-11-01
- Decision date
- 1996-03-08
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Goleta, CA
- 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
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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 |