PMA P060004S002

Device
MEL 80 EXCIMER LASER SYSTEM
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P060004
Supplement
S002
Product code
LZS
Decision date
2008-02-14
Generic name
Excimer laser system
Approval order statement
CHANGE REGARDING AN ALTERNATE LASER SOURCE.

Current openFDA PMA Record#

Device
MEL 80 EXCIMER LASER SYSTEM
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P060004
Supplement
S002
Product code
LZS
Generic name
Excimer laser system
Decision date
2008-02-14
Decision code
OK30
Date received
2008-01-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE REGARDING AN ALTERNATE LASER SOURCE.