FDA PMA FDA Class 3 Approved 🇺🇸 United States

Barrier, Absorbable, Adhesion

PMA: P880047 · Supplement: S006 · Decision May 5, 1999
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
S006
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
May 5, 1999
Date Received
August 28, 1998
Supplement Type
Normal 180 Day Track
Supplement Reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review
N

Advisory Committee Statement

Approval for a manufacturing site located at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico.

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