LENSRINS(R) STERILE PRESERVED SALINE SOLN

Accessories, Soft Lens Products

FDA Premarket Approval P810029 S002

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

DeviceLENSRINS(R) STERILE PRESERVED SALINE SOLN
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantABBOTT MEDICAL OPTICS INC
Date Received1981-06-16
Decision Date1982-07-21
PMAP810029
SupplementS002
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeSpecial (immediate Track)
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P810029Original Filing
S010 1989-09-29 Normal 180 Day Track
S009 1988-04-14 Normal 180 Day Track
S008 1987-03-16 30-Day Supplement
S007 1984-06-04
S006 1984-04-23
S005 1984-03-26
S004 1982-04-12
S003 1981-06-22
S002 1981-06-16 Special (immediate Track)
S001 1980-06-16

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