SAULFON PW-70 A&B

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P840031 S003

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

DeviceSAULFON PW-70 A&B
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantLOMBART LENSES, LTD.
Date Received1985-08-22
Decision Date1986-03-17
PMAP840031
SupplementS003
Product CodeLPM
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address LOMBART LENSES, LTD. 1215 Boissevain Ave. norfolk, VA 23507

Supplemental Filings

Supplement NumberDateSupplement Type
P840031Original Filing
S009 1998-06-25 30-day Notice
S008 1989-07-19 Normal 180 Day Track
S007 1988-03-31 Normal 180 Day Track
S006 1987-02-24 Normal 180 Day Track
S005
S004 1987-02-06 Normal 180 Day Track
S003 1985-08-22
S002
S001 1985-04-01

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