NanoFLEX One Piece Collamer Intraocular Lens (CIOL)
FDA premarket approval P990013/S038 · decided 2019-07-19
Approval details
- PMA number
- P990013
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NanoFLEX One Piece Collamer Intraocular Lens (CIOL)
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2019-04-22
- Decision date
- 2019-07-19
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).
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