IC-8 Apthera Intraocular Lens
FDA premarket approval P210005/S005 · decided 2023-07-31
Approval details
- PMA number
- P210005
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IC-8 Apthera Intraocular Lens
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2023-06-01
- Decision date
- 2023-07-31
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a manufacturing site located at Bausch & Lomb, 21 N. Park Place Blvd., Clearwater, Florida, 33759 for the following functions: 1) Receiving inspections of device raw materials/ subassemblies 2) Shipping and handling of device raw materials/subassemblies 3) Lot release and documentation review of finished devices 4) Handling, storage, preservation and distribution of finished devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.