TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003
FDA premarket approval P990080/S024 · decided 2007-07-16
Approval details
- PMA number
- P990080
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-05-09
- Decision date
- 2007-07-16
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO ADD AN ALTERNATE MANUFACTURING SITE, A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.
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