APLIGRAF(R)

FDA Premarket Approval P950032 S023

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 to introduce a new keratinocyte cell strain into the production of apligraf (i. E. , hep 663).

DeviceAPLIGRAF(R)
Generic NameDressing, Wound And Burn, Interactive
ApplicantORGANOGENESIS, INC.
Date Received2001-04-30
Decision Date2001-05-09
PMAP950032
SupplementS023
Product CodeMGR 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ORGANOGENESIS, INC. 150 Dan Rd. canton, MA 02021

Supplemental Filings

Supplement NumberDateSupplement Type
P950032Original Filing
S074 2013-07-19 30-day Notice
S073 2013-05-21 Normal 180 Day Track No User Fee
S072 2013-04-24 Real-time Process
S071 2012-12-18 Real-time Process
S070 2012-12-13 135 Review Track For 30-day Notice
S069 2012-10-31 Real-time Process
S068 2012-03-07 Real-time Process
S067 2012-02-01 Real-time Process
S066 2011-12-19 Real-time Process
S065 2011-10-27 30-day Notice
S064 2011-08-05 Real-time Process
S063 2011-03-01 Real-time Process
S062 2011-01-11 30-day Notice
S061 2010-12-08 Special (immediate Track)
S060 2010-09-22 Real-time Process
S059 2010-07-01 135 Review Track For 30-day Notice
S058 2010-06-10 Real-time Process
S057 2010-03-11 30-day Notice
S056 2010-02-12 Real-time Process
S055 2009-11-23 30-day Notice
S054 2009-11-13 Real-time Process
S053 2009-08-04 30-day Notice
S052 2009-06-18 Real-time Process
S051 2009-04-09 Real-time Process
S050 2009-02-11 30-day Notice
S049 2008-09-30 Real-time Process
S048 2008-06-17 30-day Notice
S047 2008-04-14 30-day Notice
S046 2008-03-10 Special (immediate Track)
S045 2007-10-29 Real-time Process
S044 2007-05-15 Real-time Process
S043 2006-03-02 Real-time Process
S042
S041 2005-05-26 30-day Notice
S040 2005-04-04 30-day Notice
S039
S038 2004-05-26 Real-time Process
S037 2003-12-24 30-day Notice
S036 2003-09-30 30-day Notice
S035 2003-08-18 30-day Notice
S034 2002-08-05 Normal 180 Day Track
S033 2002-07-16 30-day Notice
S032 2002-06-12 Real-time Process
S031 2002-03-25 Real-time Process
S030
S029 2002-02-04 Real-time Process
S028 2001-10-24 Normal 180 Day Track
S027 2001-10-15 Real-time Process
S026 2001-08-15 30-day Notice
S025 2001-07-19 Real-time Process
S024 2001-06-18 30-day Notice
S023 2001-04-30 Real-time Process
S022 2001-01-17 Normal 180 Day Track
S021 2000-11-21 30-day Notice
S020 2000-11-09 Normal 180 Day Track
S019 2000-11-03 Real-time Process
S018 2000-08-08 Real-time Process
S017 2000-03-07 Real-time Process
S016 1999-12-23 Normal 180 Day Track
S015 1999-09-03 30-day Notice
S014 1999-09-02 Real-time Process
S013
S012
S011 1999-04-27 Real-time Process
S010 1999-04-14 Normal 180 Day Track
S009 1999-03-25 30-day Notice
S008 1998-12-04 Normal 180 Day Track
S007 1998-11-27 Normal 180 Day Track
S006
S005
S004 1998-10-28 Normal 180 Day Track
S003
S002 1998-06-30 Normal 180 Day Track
S001 1998-06-17 30-day Notice

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