|
Device | 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 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 | S012 |
Date Received | 10/13/2005 |
Decision Date | 11/18/2005 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES IN BOTH THE INCOMING AND FINAL QUALITY INSPECTIONS FROM THE CURRENT METHOD OF A RANDOM SAMPLING OF DEVICES TO EVALUATING 100% OF THE INCOMING SHAFTS COIL DIMENSIONS AND PERFORMING DEFLECTION TESTING ON 100% OF THE FINISHED SHAFTS. |
Post-Approval Study | Show Report Schedule and Study Progress |