|
Device | Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan |
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 | S568 |
Date Received | 10/28/2016 |
Decision Date | 11/23/2016 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Iimplementation of a number of manufacturing changes previously approved for other Medtronic products. |