POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S006 · decided 2000-08-31
Approval details
- PMA number
- P970034
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2000-04-19
- Decision date
- 2000-08-31
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL TO EXTEND THE POWER RANGE FOR YOUR LENSES TO INCLUDE POWERS BETWEEN +3.5 AND -12.0 DIOPTERS (EXCLUDING ZERO DIOPTER) IN 0.5 DIOPTER INCREMENTS.
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