|
Device | FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S035 |
Date Received | 10/20/2010 |
Decision Date | 12/15/2010 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF A CATHETER CONFIGURATION FILE FOR THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER TO THE CRYOCONSOLE AND RELATED MODIFICATIONS TO THE CRYOCONSOLE MANUAL. |