LASAG MICRORUPTOR III Q-SWITCH ND:YAG

FDA Premarket Approval P840012 S007

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

DeviceLASAG MICRORUPTOR III Q-SWITCH ND:YAG
Generic NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
ApplicantMERIDIAN AG
Date Received1989-12-20
Decision Date1991-04-05
PMAP840012
SupplementS007
Product CodeLOI 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address MERIDIAN AG bierigutstrauss 7 ch-3608 thun, Be 

Supplemental Filings

Supplement NumberDateSupplement Type
P840012Original Filing
S007 1989-12-20 Normal 180 Day Track
S006 1989-12-07 Normal 180 Day Track
S005 1988-10-04 Normal 180 Day Track
S004
S003 1987-04-01 Panel Track
S002 1987-03-26 Normal 180 Day Track
S001 1986-01-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.