HYDROGEN PEROXIDE DISINFECTION SOLUTION

FDA Premarket Approval P850026 S005

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

DeviceHYDROGEN PEROXIDE DISINFECTION SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantPACO PHARMACEUTICAL SERVICES, INC.
Date Received1989-03-20
Decision Date1989-09-26
PMAP850026
SupplementS005
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address PACO PHARMACEUTICAL SERVICES, INC. 1200 Paco Way building 19 lakewood, NJ 08701

Supplemental Filings

Supplement NumberDateSupplement Type
P850026Original Filing
S006 1989-09-11 Normal 180 Day Track
S005 1989-03-20 Normal 180 Day Track
S004 1988-04-19 Normal 180 Day Track
S003 1988-01-20 Normal 180 Day Track
S002 1987-05-21 30-Day Supplement
S001 1987-05-11 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.