BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
FDA premarket approval P860040/S013 · decided 1995-11-27
Approval details
- PMA number
- P860040
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Wavetouch Technologies, LLC
- Date received
- 1995-02-28
- Decision date
- 1995-11-27
- Days to decision
- 272 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR RELOCATION OF THE ALTERNATE MANUFACTURER, WESTCON CONTACT LENS CO., FROM 2775 CROSSROADS BOULEVARD, #110, GRAND JUNCTION, CO 81506 TO 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 AND FOR A CHANGE IN THE STERILIZATION PROCESS TO INCLUDE PARAMETRIC RELEASE AT WESTCON CONTACT LENS CO., 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 FOR HORIZON 55 SPHERICAL AND HORIZON 55 TORIC (METHAFILCON A) HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR
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