SEPRAFILM ADHESION BARRIER
FDA premarket approval P950034/S047 · decided 2017-06-29
Approval details
- PMA number
- P950034
- Supplement
- S047
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SEPRAFILM ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2016-12-23
- Decision date
- 2017-06-29
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- 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
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