TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
FDA premarket approval P980040/S050 · decided 2014-10-23
Approval details
- PMA number
- P980040
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-09-24
- Decision date
- 2014-10-23
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADD A NEW OIL-FREE COMPRESSED AIR (OFCA) SYSTEM AT THE AMO ANASCO, PUERTO RICO FACILITY.
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