ANGELCHIK ANTI-REFLUX PROSTHESIS
FDA premarket approval P790006/S005 · decided 1990-10-25
Approval details
- PMA number
- P790006
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANGELCHIK ANTI-REFLUX PROSTHESIS
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Allergan, Inc.
- Date received
- 1990-06-21
- Decision date
- 1990-10-25
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
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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 |