TECNIS 1-PIECE IOL MODEL ZCB00
FDA premarket approval P980040/S022 · decided 2008-02-01
Approval details
- PMA number
- P980040
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-PIECE IOL MODEL ZCB00
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-12-21
- Decision date
- 2008-02-01
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.
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