UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S001 · decided 1998-11-20
Approval details
- PMA number
- P970034
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 1998-10-22
- Decision date
- 1998-11-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- The 30-day Notice requested approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chambera t Griffith MicroScience, the same sterilization contractor approved in the firm's original PMA. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to
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