• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecardiac ablation percutaneous catheter
Generic Namerf ablation system
PMA NumberP980003
Supplement NumberS034
Date Received12/27/2011
Decision Date02/15/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for five changes to address the failure of a micro switch designed to automatically shut off the pump if the roller bed cover is opened without turning off the power switch. These changes include: 1) introducing a new micro switch which features an auxiliary actuator which eliminates direct contact between the retainer screw and the actuator button; 2) adding a secondary shoulder on the retainer screw to limit the screw penetration depth to coincide with the tolerance stack up with the micro switch position; 3) minor dimension and tolerance changes to the mounting plate to accommodate the new micro switch; 4) use counter-sink holes instead of straight-through holes in the pump head to secure the mounting plate, ensuring bracket alignment and minimizing play in the bracket installation; and 5) adding an inspection step and test fixture to verify the installed position of the micro switch relative to the pump head.