TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE

Dressing, Wound And Burn, Interactive

FDA Premarket Approval P960007 S015

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 amended labeling to include information regarding the results of testing the donor mother's sera for viruses and other infectious agents.

DeviceTRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
Classification NameDressing, Wound And Burn, Interactive
Generic NameDressing, Wound And Burn, Interactive
ApplicantSHIRE REGENERATIVE MEDICINE
Date Received2001-06-26
Decision Date2001-08-30
PMAP960007
SupplementS015
Product CodeMGR
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SHIRE REGENERATIVE MEDICINE 11095 Torreyana Road san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P960007Original Filing
S021 2011-03-07 Normal 180 Day Track
S020 2010-11-01 135 Review Track For 30-day Notice
S019 2010-07-26 30-day Notice
S018 2003-11-17 Special (immediate Track)
S017 2002-08-22 Normal 180 Day Track No User Fee
S016 2001-11-05 Real-time Process
S015 2001-06-26 Normal 180 Day Track
S014 2000-03-01 Normal 180 Day Track
S013 1999-09-02 Normal 180 Day Track
S012
S011 1999-08-19 Normal 180 Day Track
S010
S009 1998-07-24 Normal 180 Day Track
S008 1998-07-10 Normal 180 Day Track
S007 1998-01-09 Normal 180 Day Track
S006 1997-11-24 Normal 180 Day Track
S005 1997-10-29 Normal 180 Day Track
S004 1997-10-21 Real-time Process
S003 1997-10-22 Normal 180 Day Track
S002 1997-05-05 Real-time Process
S001 1997-04-08 Real-time Process

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