MICRO YAG ND:YAG LASER SYSTEM

FDA Premarket Approval P850063 S001

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

DeviceMICRO YAG ND:YAG LASER SYSTEM
Generic NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
ApplicantSORIN GROUP USA INC.
Date Received1986-05-19
Decision Date1986-06-17
PMAP850063
SupplementS001
Product CodeLOI 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address SORIN GROUP USA INC. 14401 West 65th Way arvada, CO 80004

Supplemental Filings

Supplement NumberDateSupplement Type
P850063Original Filing
S001 1986-05-19

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