POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S005 · decided 2000-03-27
Approval details
- PMA number
- P970034
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2000-02-14
- Decision date
- 2000-03-27
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for reducing the frequency of ethylene chlorohydrin residual testing from a quarterly basis to an annual basis.
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