ND:YAG POSTERIOR CAPSULOTOMY MODEL 100

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

FDA Premarket Approval P830062 S010

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

DeviceND:YAG POSTERIOR CAPSULOTOMY MODEL 100
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
ApplicantNIDEK, INC.
Date Received1986-09-02
Decision Date1986-12-01
PMAP830062
SupplementS010
Product CodeLOI
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address NIDEK, INC. 47651 Westinghouse Dr. fremont, CA 94539

Supplemental Filings

Supplement NumberDateSupplement Type
P830062Original Filing
S016 1990-01-12 Normal 180 Day Track
S015 1989-08-08 Normal 180 Day Track
S014 1989-04-10 Normal 180 Day Track
S013
S012 1988-03-15 Normal 180 Day Track
S011 1987-03-23 Normal 180 Day Track
S010 1986-09-02 Normal 180 Day Track
S009 1986-03-19
S008
S007 1985-09-16
S006 1985-03-04
S005
S004
S003
S002 1984-10-15
S001 1984-07-12

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