|
Device | CAPSURE SPZ/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/VITATRON IMPULSE/IMPULSE II |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S067 |
Date Received | 07/15/2010 |
Decision Date | 08/13/2010 |
Product Code |
NVY |
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 IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE. |