CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.
FDA premarket approval P960034 · decided 1998-08-12
Approval details
- PMA number
- P960034
- Trade name
- CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 1996-10-01
- Decision date
- 1998-08-12
- Days to decision
- 680 days
- Decision code
- APWD
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for lens models with the heparin surface modification applied to all your single-piece PMMA lenses approved in P810055. These models will be specified with a "C" following the number designation for the corresponding non-HSM PMMA model. The lenses will be marketed under the trade name CeeOn(TM) HSM PMMA IOLs. This device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by an extracapsular cataract extraction
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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 |