TECNIS 1-Piece Multifocal IOLs; TECNIS Symfony Extended Range of Vision (EVR) IOL., TECNIS Symfony Toric ERV IOLs
FDA premarket approval P980040/S074 · decided 2016-10-04
Approval details
- PMA number
- P980040
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-Piece Multifocal IOLs; TECNIS Symfony Extended Range of Vision (EVR) IOL., TECNIS Symfony Toric ERV IOLs
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-09-09
- Decision date
- 2016-10-04
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Modification to and qualification for a new supplier for the PMMA tumbling cups used in IOL manufacturing.
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