FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

Barrier, Absorbable, Adhesion

PMA: P880047 · Supplement: S011 · Decision Nov 21, 2006
Classifications
1
FEI Numbers
17
Registration Numbers
17

Basic Information

Device Name
Barrier, Absorbable, Adhesion
Trade Name
INTERCEED ABSORBABLE ADHESION BARRIER
PMA Number
P880047
Supplement Number
S011
Device Class
FDA Class 3
Product Code
MCN
Generic Name
Barrier, absorbable, adhesion
Medical Specialty
Unknown
Advisory Committee
Obstetrics/Gynecology
Decision
30-Day Notice Accepted
Decision Code
OK30
Decision Date
November 21, 2006
Date Received
October 25, 2006
Supplement Type
30-Day Notice
Supplement Reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review
N

Advisory Committee Statement

CHANGE IN THE PACKAGING MATERIAL.

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