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.
Device | STERICON SALINE SOLUTION |
Classification Name | Accessories, Soft Lens Products |
Generic Name | Accessories, Soft Lens Products |
Applicant | AUTOMATIC LIQUID PACKAGING, INC. |
Date Received | 1989-04-26 |
Decision Date | 1989-09-18 |
PMA | P850070 |
Supplement | S003 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | AUTOMATIC LIQUID PACKAGING, INC. 2200 W. Lake Shore Dr. woodstock, IL 60098 |
Supplement Number | Date | Supplement Type |
---|---|---|
P850070 | Original Filing | |
S010 | 1997-06-04 | Normal 180 Day Track |
S009 | 1997-02-14 | Normal 180 Day Track |
S008 | 1995-11-03 | Normal 180 Day Track |
S007 | ||
S006 | 1990-08-28 | Normal 180 Day Track |
S005 | 1990-03-27 | Normal 180 Day Track |
S004 | 1989-10-25 | Normal 180 Day Track |
S003 | 1989-04-26 | Normal 180 Day Track |
S002 | 1987-06-17 | Normal 180 Day Track |
S001 |