SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno
FDA premarket approval P980040/S110 · decided 2019-11-22
Approval details
- PMA number
- P980040
- Supplement
- S110
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2019-11-08
- Decision date
- 2019-11-22
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Consolidation of the cosmetic inspection for the one-piece intraocular lenses packaged in the SmartLOAD Delivery Technology and TECNIS Simplicity Delivery System manufactured at the AMO Puerto Rico facility.
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