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 redesign of the star thyratron trigger board(p/n 0040-0044).
| Device | STAR EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2014-07-07 |
| Decision Date | 2014-10-02 |
| PMA | P910062 |
| Supplement | S007 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910062 | Original Filing | |
| S008 | 2018-12-31 | Real-time Process |
| S007 | 2014-07-07 | Real-time Process |
| S006 | 2014-05-19 | 30-day Notice |
| S005 | ||
| S004 | 2014-05-01 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2000-04-12 | Real-time Process |