FDA PMA 30-Day Notice Accepted 🇺🇸 United States

PMA: P010031 · Supplement: S244 · Decision May 5, 2011
Classifications
0
FEI Numbers
0
Registration Numbers
0

Basic Information

Trade Name
PROTECTA/PROTECTA XT CRT-DS
PMA Number
P010031
Supplement Number
S244
Advisory Committee
Cardiovascular
Decision
30-Day Notice Accepted
Decision Code
OK30
Decision Date
May 5, 2011
Date Received
April 5, 2011
Supplement Type
30-Day Notice
Supplement Reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review
N

Advisory Committee Statement

MOVING STERILIZATION EQUIPMENT WITHIN A FACILITY AND IMPLEMENTATION OF A BAR CODE READER SYSTEM.