TECNIS OPTIBLUE 1-PIECE IOL
FDA premarket approval P980040/S048 · decided 2014-07-24
Approval details
- PMA number
- P980040
- Supplement
- S048
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS OPTIBLUE 1-PIECE IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-06-13
- Decision date
- 2014-07-24
- Days to decision
- 41 days
- Decision code
- APPR
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., IN ANASCO, PUERTO RICO.
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