POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S004 · decided 2000-04-28
Approval details
- PMA number
- P970034
- Supplement
- S004
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2000-02-14
- Decision date
- 2000-04-28
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for Allergan Surgical to distribute the Models RS-50B, RS-55B, RS-60B, RS-65, SP-60A, and SP-65A2 ultraviolet-absorbing posterior chamber intraocular lenses as Allergan's Duralens Models 52, 53, 54, 59, 60, and 65T, respectively.
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