NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Premarket Approval P830054 S011

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 OPHTHALMIC LASER SYSTEM 9900
Classification NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Generic NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
ApplicantCOHERENT MEDICAL DIVISION
Date Received1986-07-08
Decision Date1986-09-25
PMAP830054
SupplementS011
Product CodeLOI
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address COHERENT MEDICAL DIVISION 3270 West Bayshore Rd. p.o. Box 10122 palo Alto, CA 94303

Supplemental Filings

Supplement NumberDateSupplement Type
P830054Original Filing
S022 1989-08-03 Normal 180 Day Track
S021 1988-05-18 Normal 180 Day Track
S020 1987-07-08 Normal 180 Day Track
S019 1987-04-30 Normal 180 Day Track
S018 1987-04-01 Normal 180 Day Track
S017 1987-03-09 Normal 180 Day Track
S016 1986-10-10 Normal 180 Day Track
S015 1986-09-09 Normal 180 Day Track
S014
S013 1986-09-08 Normal 180 Day Track
S012 1986-09-08 Normal 180 Day Track
S011 1986-07-08 Normal 180 Day Track
S010 1986-07-08 Normal 180 Day Track
S009 1986-05-28 Normal 180 Day Track
S008
S007
S006 1985-06-21
S005 1985-01-03
S004
S003 1984-12-10 Normal 180 Day Track
S002 1984-11-27
S001 1984-11-20

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