|
Device | MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P930039 |
Supplement Number | S152 |
Date Received | 05/03/2016 |
Decision Date | 10/25/2016 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility. |