TECNIS 1-PIECE LENS
FDA premarket approval P980040/S042 · decided 2013-03-07
Approval details
- PMA number
- P980040
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-PIECE LENS
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2013-02-12
- Decision date
- 2013-03-07
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- NEW IOL PRODUCTION LINE, TEMPORARY CLEAN/INSPECT/INSERT AREA, A MODIFIED DEIONIZED WATER LOOP SUPPORT AREA AND A MODIFIED COMPRESSED AIR SYSTEM LOOP SUPPORT PRODUCTION AREA.
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