TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P
FDA premarket approval P980040/S054 · decided 2014-12-17
Approval details
- PMA number
- P980040
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-11-18
- Decision date
- 2014-12-17
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ALTERNATE MOLDING SUPPLIER FOR THE LOWER BODY AND PROTECTOR CAP COMPONENTS OF THE TECNIS ITEC PRELOAD DELIVERY SYSTEM.
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