LENSRINS(R) STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P810029 S009

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 SOLUTION
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantABBOTT MEDICAL OPTICS INC
Date Received1988-04-14
Decision Date1988-08-31
PMAP810029
SupplementS009
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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