Lens Optic body diameter cut
FDA premarket approval P100016/S005 · decided 2018-03-06
Approval details
- PMA number
- P100016
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lens Optic body diameter cut
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2018-02-08
- Decision date
- 2018-03-06
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Addition of an alternate lathing machine.
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