Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
FDA premarket approval P980040/S078 · decided 2017-03-23
Approval details
- PMA number
- P980040
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2017-02-22
- Decision date
- 2017-03-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Add the AMO Kulim, Malaysia manufacturing site for your Tecnis Multifocal IOL Models ZKB00, ZLB00, and ZMB00.
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