BOSTON LENS(R) CONDITIONING SOLUTION

FDA Premarket Approval P820070 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

DeviceBOSTON LENS(R) CONDITIONING SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantPOLYMER TECHNOLOGY CORP.
Date Received1986-07-30
Decision Date1987-12-01
PMAP820070
SupplementS011
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address POLYMER TECHNOLOGY CORP. 1400 N. Goodman St. rochester, NY 14692

Supplemental Filings

Supplement NumberDateSupplement Type
P820070Original Filing
S015 1989-10-17 Normal 180 Day Track
S014 1988-11-09 Normal 180 Day Track
S013 1988-01-25 Normal 180 Day Track
S012 1987-10-26 Special (immediate Track)
S011 1986-07-30 Normal 180 Day Track
S010
S009 1984-08-16
S008 1984-07-10
S007 1984-05-22
S006 1984-04-23
S005 1984-03-27
S004 1984-02-15
S003 1984-02-07
S002 1984-02-07
S001 1983-12-22

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