|
Device | CapSureFix Novus Lead 5076; Vitatron Crystalline |
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 | S150 |
Date Received | 03/23/2016 |
Decision Date | 04/18/2016 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Additional supplier for the electrode ring and helix assembly. |