|
Device | CAPSURE SENSE LEAD,VITATRON CRYSTALLINE LEAD |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P830061 |
Supplement Number | S101 |
Date Received | 11/27/2013 |
Decision Date | 12/12/2013 |
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 SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY. |