MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL)
FDA premarket approval P960036/S004 · decided 2001-03-16
Approval details
- PMA number
- P960036
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL)
- Generic name
- intraocular lens
- Applicant
- Ioltech, S.A.
- Date received
- 2000-09-18
- Decision date
- 2001-03-16
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Penbroke, MA
- Statement
- APPROVAL FOR THE CHANGE OF THE VIAL MATERIAL FROM GLASS TO PLASTIC FOR THE MEMORY LENS(R) IOL.
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