SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
FDA premarket approval P980040/S005 · decided 2003-12-15
Approval details
- PMA number
- P980040
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2003-10-31
- Decision date
- 2003-12-15
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES TO THE ACRYLIC BUTTON ANNEALING CYCLE.
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