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Device | FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S041 |
Date Received | 12/16/2011 |
Decision Date | 01/13/2012 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement STREAMLINING THE INSPECTION PROCEDURE FOR THE FREEZOR FAMILY OF CATHETERS. |
Post-Approval Study | Show Report Schedule and Study Progress |