|
Device | FREEZOR,FREEZOR XTRA & FREEZOR MAX 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 | S021 |
Date Received | 01/09/2007 |
Decision Date | 04/18/2007 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LEAK DETECTION SYSTEM IN THE FREEZOR CATHETER AND FREEZOR XTRA DEVICES FROM A SINGLE BARE STAINLESS STEEL WIRE TO A DUPLEX INSULATED WIRE MADE OF TWO ELECTRODES. |