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.
Change of the frame grabber printed circuit board (pcb) of the star system.
Device | STAR S4 IM EXCIMER LASER SYSTEM |
Classification Name | Excimer Laser System |
Generic Name | Excimer Laser System |
Applicant | AMO Manufacturing USA, LLC |
Date Received | 2014-05-01 |
Decision Date | 2014-05-30 |
PMA | P910062 |
Supplement | S004 |
Product Code | LZS |
Advisory Committee | Ophthalmic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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 |