PMA P990010S004

Device
STAR, S41R EXCIMER LASER SYSTEM
Applicant
Amo Manufacturing USA, LLC
PMA number
P990010
Supplement
S004
Product code
LZS
Decision date
2014-05-30
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
CHANGE OF THE FRAME GRABBER PRINTED CIRCUIT BOARD (PCB) OF THE STAR SYSTEM.

Current openFDA PMA Record#

Device
STAR, S41R EXCIMER LASER SYSTEM
Applicant
Amo Manufacturing USA, LLC
PMA number
P990010
Supplement
S004
Product code
LZS
Generic name
Excimer laser system
Decision date
2014-05-30
Decision code
OK30
Date received
2014-05-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE OF THE FRAME GRABBER PRINTED CIRCUIT BOARD (PCB) OF THE STAR SYSTEM.