APLIGRAF

Dressing, Wound And Burn, Interactive

FDA Premarket Approval P950032 S044

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 for a new cell strain, hep 040, for introduction into production of apligraf. The device, as modified, will be marketed under the trade name apligraf and is indicated for the treatment of partial and full thickness chronic venous ulcers.

DeviceAPLIGRAF
Classification NameDressing, Wound And Burn, Interactive
Generic NameDressing, Wound And Burn, Interactive
ApplicantORGANOGENESIS, INC.
Date Received2007-05-15
Decision Date2007-07-13
PMAP950032
SupplementS044
Product CodeMGR
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
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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