UV-PMMA PCL'S
FDA premarket approval P970034/S003 · decided 1999-04-16
Approval details
- PMA number
- P970034
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UV-PMMA PCL'S
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 1999-03-23
- Decision date
- 1999-04-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- The 30-day Notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at Griffith MicroScience, the same sterilization contractor approved in the original PMA. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air
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