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 adding a visibility tint to the contact lens and revised labeling for the spherical lens to reflect the addition ofthe visibility tint. There are no changes in the previously approved indications for use.
| Device | BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | WAVETOUCH TECHNOLOGIES, LLC |
| Date Received | 1997-04-01 |
| Decision Date | 1997-11-04 |
| PMA | P860040 |
| Supplement | S014 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |