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.
Manufacturing changes to include the installation and qualification of new (i. E. , replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the batam, indonesia production facility.
| Device | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2016-02-26 |
| Decision Date | 2016-03-23 |
| PMA | P000030 |
| Supplement | S002 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000030 | Original Filing | |
| S003 | 2016-06-01 | 30-day Notice |
| S002 | 2016-02-26 | 30-day Notice |
| S001 | 2016-02-16 | 30-day Notice |