CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)
FDA premarket approval P880070/S011 · decided 2005-02-04
Approval details
- PMA number
- P880070
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)
- Generic name
- intraocular lens
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 2005-01-03
- Decision date
- 2005-02-04
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
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510(k) clearances by this applicant
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|---|---|---|
| Catalys Precision Laser System (K170322) | Abbott Medical Optics, Inc. | 2017-05-19 |
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| 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 |