FDA PMA 30-Day Notice Accepted 🇺🇸 United States

PMA: P010031 · Supplement: S321 · Decision Aug 14, 2012
Classifications
0
FEI Numbers
0
Registration Numbers
0

Basic Information

Trade Name
CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
PMA Number
P010031
Supplement Number
S321
Advisory Committee
Cardiovascular
Decision
30-Day Notice Accepted
Decision Code
OK30
Decision Date
August 14, 2012
Date Received
July 19, 2012
Supplement Type
30-Day Notice
Expedited Review
N

Advisory Committee Statement

UPDATES TO THE HYBRID TESTING PROCESS.