CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS
FDA premarket approval P960034/S002 · decided 2007-05-08
Approval details
- PMA number
- P960034
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS
- Generic name
- intraocular lens
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 2007-04-12
- Decision date
- 2007-05-08
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.
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