PMA P950034S005

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S005
Product code: MCN
Decision date: 1998-02-25
Generic name: Barrier, absorbable, adhesion
Approval order statement: In this supplment the applicant agrees to submit an Investigational Device Exemptions (IDE) application for the modified postapproval safety study, is approved. We believe that this study, with the modifications as discussed, will satisfy the condition ofapproval for this PMA, but we may have additional comments on the IDE botha s it related to the objectives of the postapproval study, depending on your responses, and your objective of collecting outcomes data on the incidence of small bowel obstruction.

Current openFDA PMA Record#

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S005
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 1998-02-25
Decision code: APPR
Date received: 1997-04-16
Supplement type: Real-Time Process
Supplement reason: Postapproval Study Protocol
Approval order statement: In this supplment the applicant agrees to submit an Investigational Device Exemptions (IDE) application for the modified postapproval safety study, is approved. We believe that this study, with the modifications as discussed, will satisfy the condition ofapproval for this PMA, but we may have additional comments on the IDE botha s it related to the objectives of the postapproval study, depending on your responses, and your objective of collecting outcomes data on the incidence of small bowel obstruction.