SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES
FDA premarket approval P960039/S003 · decided 2008-03-03
Approval details
- PMA number
- P960039
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Unilens Corporation, USA
- Date received
- 2007-12-31
- Decision date
- 2008-03-03
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Largo, FL
- Statement
- APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.
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