Collamer Intraocular Lens - Alternat Environmental Monitoring Provider
FDA premarket approval P990013/S039 · decided 2019-07-26
Approval details
- PMA number
- P990013
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collamer Intraocular Lens - Alternat Environmental Monitoring Provider
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2019-06-27
- Decision date
- 2019-07-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Addition of the microbiology laboratory at the STAAR Surgical, Monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices.
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