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PMA P950034S047

Device
SEPRAFILM ADHESION BARRIER
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S047
Product code
MCN
Decision date
2017-06-29
Generic name
Barrier, absorbable, adhesion
Approval order statement
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.

Current openFDA PMA Record#

Device
SEPRAFILM ADHESION BARRIER
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S047
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2017-06-29
Decision code
APPR
Date received
2016-12-23
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
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.