Collamer UV Absorbing Posterior Chamber Intraocular Lens
FDA premarket approval P990013/S037 · decided 2017-08-04
Approval details
- PMA number
- P990013
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collamer UV Absorbing Posterior Chamber Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2017-07-06
- Decision date
- 2017-08-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Addition of an autoclave for use in the sterilization of the Visian Implantable Collamer Lens (ICL) and the Collamer Intraocular Lens (CIOL) at the Monrovia, California facility.
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