HEALON D
FDA premarket approval P880031/S014 · decided 2008-08-22
Approval details
- PMA number
- P880031
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEALON D
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 2007-02-15
- Decision date
- 2008-08-22
- Days to decision
- 554 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL TO MOVE THE MANUFACTURE OF VITRAX FROM THE ALLERGAN FACILITY IN WESTPORT, IRELAND TO THE AMO UPPSALA FACILITY IN SWEDEN, FOR A 0.4 ML FILL VOLUME IN ADDITION TO THE CURRENTLY APPROVED 0.65 ML FILL VOLUME, AND RE-BRAND THE DISPERSIVE VITRAX PRODUCT MANUFACTURED IN UPPSALA, SWEDEN AS HEALON D (DISPERSIVE).
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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 |