MEL 80 EXCIMER LASER SYSTEM

FDA Premarket Approval P060004 S002

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.

Pre-market Approval Supplement Details

Change regarding an alternate laser source.

DeviceMEL 80 EXCIMER LASER SYSTEM
Generic NameExcimer Laser System
ApplicantCarl Zeiss Meditec, Inc.
Date Received2008-01-18
Decision Date2008-02-14
PMAP060004
SupplementS002
Product CodeLZS 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568

Supplemental Filings

Supplement NumberDateSupplement Type
P060004Original Filing
S002 2008-01-18 30-day Notice
S001 2007-12-28 Panel Track

NIH GUDID Devices

Device IDPMASupp
04049471000221 P060004 001
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