MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)
FDA premarket approval P960036 · decided 1997-12-22
Approval details
- PMA number
- P960036
- Trade name
- MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)
- Generic name
- intraocular lens
- Applicant
- Ioltech, S.A.
- Date received
- 1996-10-01
- Decision date
- 1997-12-22
- Days to decision
- 447 days
- Decision code
- APWD
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Penbroke, MA
- Statement
- Approval for the MemoryLens(TM) Model U940A ultraviolet-absorbing hydrophilic posterior chamber intraocular lens. This device is indicated for primary implantation for the visual correction of aphakia in patients sixty years of age or older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.
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