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 1) a change in manufacturing method from lathe-cut to cast-molded; 2) a change in handling tint from vat dyes to d & c green #6; 3) to add an ultraviolet absorber into netrafilcon a lens material; 4) an alternate manufacturing site at wesley jessen pbh, ltd. , southampton, united kingdom; 5) modification to the indicatinos for use including the sentence "gentle touch(tm) uv (netrafilcon a) soft (hydrophilic) contact lenses help to protect against the transmission of harmful uv radiation to the cornea and into the eye"; and 6) modification of the note and warning in labeling.
| Device | GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1999-03-25 |
| Decision Date | 2000-09-12 |
| PMA | P890012 |
| Supplement | S004 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890012 | Original Filing | |
| S005 | 2000-02-28 | Normal 180 Day Track |
| S004 | 1999-03-25 | Normal 180 Day Track |
| S003 | 1994-10-06 | 30-Day Supplement |
| S002 | 1990-12-28 | Normal 180 Day Track |
| S001 | 1989-09-25 | Normal 180 Day Track |