Collamer Intraocular Lens (CIOL)
FDA premarket approval P990013/S041 · decided 2021-07-19
Approval details
- PMA number
- P990013
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collamer Intraocular Lens (CIOL)
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2021-06-22
- Decision date
- 2021-07-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Adding an alternative facility for water and pre-sterile product bioburden testing.
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