SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
FDA premarket approval P960039/S001 · decided 1998-07-09
Approval details
- PMA number
- P960039
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Unilens Corporation, USA
- Date received
- 1998-06-25
- Decision date
- 1998-07-09
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Largo, FL
- Statement
- Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
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