AMO VITRAX (SODIUM HYALURONATE)
FDA premarket approval P880031/S010 · decided 1996-04-08
Approval details
- PMA number
- P880031
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMO VITRAX (SODIUM HYALURONATE)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 1995-11-24
- Decision date
- 1996-04-08
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- USE OF "PHARMACEUTICAL GRADE" SODIUM HYALURONATE POWDER SUPPLIED BY AKZO NOBEL CORPORATION, DIOSYNTH BV, KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDS, AS AN ALTERNATE SUPPLY OF SODIUM HYALURONATE POWDER FOR USE IN THE MANUFACTURE OF AMO VITRAX SODIUM HYALURONATE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Catalys Precision Laser System (K170322) | Abbott Medical Optics, Inc. | 2017-05-19 |
| Dual Pump Pack (K160236) | Abbott Medical Optics, Inc. | 2016-04-27 |
| AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (K151636) | Abbott Medical Optics, Inc. | 2015-10-19 |
| COMPACT INTUITIV Multiple-Use Pack (K151783) | Abbott Medical Optics, Inc. | 2015-09-02 |
| One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series (K143434) | Abbott Medical Optics, Inc. | 2015-05-06 |
| COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK (K133115) | Abbott Medical Optics, Inc. | 2014-02-27 |
| LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (K121721) | Abbott Medical Optics, Inc. | 2012-10-15 |
| IFS LASER SYSTEM (K113151) | Abbott Medical Optics, Inc. | 2012-03-08 |