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Device | FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S029 |
Date Received | 03/15/2010 |
Decision Date | 10/29/2010 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CRYOCATH LP IN POINT CLAIRE, QUEBEC FOR WAREHOUSING AND PERFORMING INCOMING INSPECTIONS. |