SEPRAFILM BIORESORBABLE MEMBRANE

FDA premarket approval P950034/S005 · decided 1998-02-25

Approval details

PMA number

P950034

Supplement

S005

Supplement type

Real-Time Process

Supplement reason

Postapproval Study Protocol

Trade name

SEPRAFILM BIORESORBABLE MEMBRANE

Generic name

Barrier, absorbable, adhesion

Applicant

Baxter Healthcare Corporation

Date received

1997-04-16

Decision date

1998-02-25

Days to decision

315 days

Decision code

APPR

Product code

MCN

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Deerfield Lake, IL

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 obs

510(k) clearances by this applicant