TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS
FDA premarket approval P080010/S002 · decided 2009-06-19
Approval details
- PMA number
- P080010
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2009-04-28
- Decision date
- 2009-06-19
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.
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