TRANSCYTE

Dressing, Wound And Burn, Interactive

FDA Premarket Approval P960007 S008

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 changing the name of the product from dermagraft-tc to transcyte(tm) and for minor editoral changes to the directions for use and product label. The device, as modified, will be marketed under the trade name transcyte(tm) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.

DeviceTRANSCYTE
Classification NameDressing, Wound And Burn, Interactive
Generic NameDressing, Wound And Burn, Interactive
ApplicantSHIRE REGENERATIVE MEDICINE
Date Received1998-07-10
Decision Date1998-08-14
PMAP960007
SupplementS008
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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