BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR

Lens, Contact, Orthokeratology, Overnight

FDA Premarket Approval P010062 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

Approval of revisions to the post-approval regression analysis protocol.

DeviceBOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR
Classification NameLens, Contact, Orthokeratology, Overnight
Generic NameLens, Contact, Orthokeratology, Overnight
ApplicantBAUSCH & LOMB
Date Received2005-04-18
Decision Date2006-02-21
PMAP010062
SupplementS003
Product CodeNUU
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address BAUSCH & LOMB 1400 North Goodman St. rochester, NY 14603-0450

Supplemental Filings

Supplement NumberDateSupplement Type
P010062Original Filing
S011 2018-05-25 Real-time Process
S010 2016-06-27 30-day Notice
S009 2011-05-31 30-day Notice
S008 2010-10-20 Normal 180 Day Track No User Fee
S007 2009-10-13 Normal 180 Day Track No User Fee
S006 2008-01-31 Real-time Process
S005 2006-12-21 Real-time Process
S004 2006-01-27 135 Review Track For 30-day Notice
S003 2005-04-18 Normal 180 Day Track No User Fee
S002 2004-09-01 Real-time Process
S001 2004-07-06 Real-time Process

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