|
Device | Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S560 |
Date Received | 09/08/2016 |
Decision Date | 11/17/2016 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software modification to the MyCareLink Patient Monitor Model 24950. |