MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS
FDA premarket approval P880070/S010 · decided 2004-03-17
Approval details
- PMA number
- P880070
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS
- Generic name
- intraocular lens
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 2003-11-07
- Decision date
- 2004-03-17
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL TO CHANGE THE MATERIAL AND THE MANUFACTURING PROCESS, TO ADD A HEPARIN SURFACE MODIFICATION, AND TO CHANGE THE LENS MODEL DESIGNATION FORM UV65B TO HSM65.
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