MODEL SA40N ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA premarket approval P960028/S029 · decided 2008-02-27
Approval details
- PMA number
- P960028
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL SA40N ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2008-01-28
- Decision date
- 2008-02-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CONSOLIDATION OF ATTRIBUTE AND VARIABLE INSPECTIONS BY USING CERTIFIED AND CALIBRATED GO/NO-GO OVERLAYS.
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