|
Device | CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P830061 |
Supplement Number | S134 |
Date Received | 09/02/2016 |
Decision Date | 09/28/2016 |
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 | No |
Approval Order Statement Additional supplier for stylet components. |