|
Device | CAPSURE Z/CAPSURE Z/SP NOVUS & VITATRON IMPULSE & IMPLUSE II & VIATRON EXCELLENCE SS + |
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 | S061 |
Date Received | 02/05/2009 |
Decision Date | 03/06/2009 |
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 ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE. |