|
Device | CCT.2 CRYOABLATION CONSOLE SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S014 |
Date Received | 12/20/2005 |
Decision Date | 04/06/2006 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE FOOTSWITCH, ADDITIONAL EP CONNECTIVITY, ADDITIONAL EFFICIENCY IN VERIFICATION AND VALIDATION REPORTING, AND THE OTHER MINOR CHANGES LISTED ON PAGE 2 OF THE SUBMISSION. |