SEPRAFILM ADHESION BARRIER

FDA Premarket Approval P950034 S047

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 revision of product labeling to update information that is to be provided to patients and physicians about the risks associated with use of seprafilm®. The revisions include contraindication statements regarding use of seprafilm® in patients with a history of hypersensitivity to seprafilm® and against use of seprafilm® being wrapped directly around a fresh anastomotic suture or staple line. Additional product labeling includes new warnings regarding the use of seprafilm® in patients with infections in the abdominopelvic cavity, patients with abdominopelvic malignancies, the placement of seprafilm® in locations other than directly associated with the surgical incision lines, use in patients with ongoing local and/or systemic inflammatory cell responses, seprafilm® use in the presence of other implants, and use in patients requiring re-operation within a 4 week, post-operative period. Furthermore, the change of a current precaution to a warning regarding potential foreign body reactions to seprafilm® was identified. Finally, the current precaution noting that safety and effectiveness information for use of seprafilm® in pregnant women has been revised to specifically include pregnant patients undergoing cesarean section surgical procedures.

DeviceSEPRAFILM ADHESION BARRIER
Generic NameBarrier, Absorbable, Adhesion
ApplicantGENZYME CORP.
Date Received2016-12-23
Decision Date2017-06-29
PMAP950034
SupplementS047
Product CodeMCN 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address GENZYME CORP. 52 Binney Street cambridge, MA 02142

Supplemental Filings

Supplement NumberDateSupplement Type
P950034Original Filing
S055 2022-11-23 30-day Notice
S054
S053 2021-05-11 30-day Notice
S052 2021-03-05 30-day Notice
S051
S050 2018-02-08 30-day Notice
S049 2017-09-27 30-day Notice
S048 2017-08-04 30-day Notice
S047 2016-12-23 Special (immediate Track)
S046 2016-10-18 30-day Notice
S045 2015-12-15 30-day Notice
S044 2015-12-10 30-day Notice
S043 2015-10-29 30-day Notice
S042 2014-07-14 30-day Notice
S041 2012-02-16 Normal 180 Day Track No User Fee
S040 2011-06-13 135 Review Track For 30-day Notice
S039 2010-12-10 30-day Notice
S038 2010-11-22 30-day Notice
S037 2010-10-29 Real-time Process
S036 2010-10-08 30-day Notice
S035 2010-09-27 30-day Notice
S034 2010-09-07 30-day Notice
S033 2010-08-16 30-day Notice
S032 2009-11-02 30-day Notice
S031 2008-06-09 Special (immediate Track)
S030
S029
S028 2005-11-18 30-day Notice
S027 2005-01-06 Normal 180 Day Track No User Fee
S026 2003-08-05 Real-time Process
S025 2003-04-30 30-day Notice
S024 2003-03-27 30-day Notice
S023 2003-02-25 30-day Notice
S022 2002-09-24 Real-time Process
S021 2002-03-01 30-day Notice
S020 2001-08-29 30-day Notice
S019
S018 2001-08-20 Real-time Process
S017 2000-11-28 Real-time Process
S016 2000-05-30 Real-time Process
S015 2000-05-24 30-day Notice
S014 2000-02-18 Real-time Process
S013 1999-08-09 30-day Notice
S012 1999-08-03 30-day Notice
S011 1999-02-11 Real-time Process
S010 1998-12-22 30-day Notice
S009
S008 1998-01-28 Real-time Process
S007 1997-08-19 Normal 180 Day Track
S006 1997-06-02 Real-time Process
S005 1997-04-16 Real-time Process
S004
S003 1996-11-22 Real-time Process
S002 1996-11-18 Normal 180 Day Track
S001 1996-10-22 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00358468664211 P950034 000
35413765589622 P950034 000
35413765589639 P950034 000
35413765589646 P950034 000
35413765589653 P950034 000
00358468430120 P950034 000
00358468664112 P950034 000
35413765589615 P950034 000
00358468508621 P950034 017
00358468638014 P950034 037

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