This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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
| Device | BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | WAVETOUCH TECHNOLOGIES, LLC |
| Date Received | 1995-02-28 |
| Decision Date | 1995-11-27 |
| PMA | P860040 |
| Supplement | S013 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WAVETOUCH TECHNOLOGIES, LLC 15970 Bernardo Center Dr. san Diego, CA 92127 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860040 | Original Filing | |
| S016 | 2004-05-05 | Normal 180 Day Track No User Fee |
| S015 | 1998-05-19 | Normal 180 Day Track |
| S014 | 1997-04-01 | Normal 180 Day Track |
| S013 | 1995-02-28 | Normal 180 Day Track |
| S012 | 1993-04-28 | Normal 180 Day Track |
| S011 | 1992-01-23 | Normal 180 Day Track |
| S010 | 1991-08-27 | Normal 180 Day Track |
| S009 | 1990-09-17 | Normal 180 Day Track |
| S008 | 1990-09-04 | Normal 180 Day Track |
| S007 | 1989-08-28 | Normal 180 Day Track |
| S006 | 1989-06-19 | Normal 180 Day Track |
| S005 | ||
| S004 | 1989-06-01 | Normal 180 Day Track |
| S003 | 1989-03-14 | Normal 180 Day Track |
| S002 | 1987-07-02 | Normal 180 Day Track |
| S001 | 1987-02-10 | Normal 180 Day Track |