Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI |
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 | S081 |
Date Received | 10/22/2012 |
Decision Date | 11/19/2012 |
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 AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS. |
|
|