SENSAR 1-PIECE INTRAOCULAR LENS (IOL)
FDA premarket approval P980040/S059 · decided 2015-05-15
Approval details
- PMA number
- P980040
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENSAR 1-PIECE INTRAOCULAR LENS (IOL)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-02-20
- Decision date
- 2015-05-15
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR LABELING CHANGES FOR THE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AAB00.
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