NEODYMIUM-YAG OP LASER OPL-3

FDA Premarket Approval P830064 S003

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

DeviceNEODYMIUM-YAG OP LASER OPL-3
Generic NameLaser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
ApplicantCOBURN OPTICAL IND., INC.
Date Received1985-08-08
Decision Date1986-05-28
PMAP830064
SupplementS003
Product CodeLXS 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address COBURN OPTICAL IND., INC. proffessional Products Div. po Box 2498 clearwater, FL 33517

Supplemental Filings

Supplement NumberDateSupplement Type
P830064Original Filing
S003 1985-08-08
S002 1984-11-07
S001 1984-10-11

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