|
Device | FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S028 |
Date Received | 03/08/2010 |
Decision Date | 08/06/2010 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A NEW POUCH SEALER EQUIPMENT. |