FDA PMA FDA Class 3 Approved 🇺🇸 United States

Barrier, Absorbable, Adhesion

PMA: P880047 · Supplement: S010 · Decision Jul 3, 2006
Classifications
1
FEI Numbers
17
Registration Numbers
17

Basic Information

Device Name
Barrier, Absorbable, Adhesion
Trade Name
INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
PMA Number
P880047
Supplement Number
S010
Device Class
FDA Class 3
Product Code
MCN
Generic Name
Barrier, absorbable, adhesion
Medical Specialty
Unknown
Advisory Committee
Obstetrics/Gynecology
Decision
Approved
Decision Code
APPR
Decision Date
July 3, 2006
Date Received
February 28, 2006
Supplement Type
Normal 180 Day Track
Supplement Reason
Change Design/Components/Specifications/Material
Expedited Review
N

Advisory Committee Statement

APPROVAL FOR A CHANGE TO THE YARN USED IN THE DEVICE.

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
MCN Barrier, Absorbable, Adhesion