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 to relocate some manufacturing processes to the site located at american biocurve, inc. , san diego, california.
| Device | BIOCURVE SOFT CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | WAVETOUCH TECHNOLOGIES, LLC |
| Date Received | 2004-05-05 |
| Decision Date | 2004-05-28 |
| PMA | P860040 |
| Supplement | S016 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Express Gmp Supplement |
| 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 |