• 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 | 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.
 
Trade NameRF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS017
Date Received03/18/2002
Decision Date05/31/2002
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 ablation catheters which feature design changes to the performer catheter. The device, as modified, will be marked under the trade name rf enhancer 7french, 5 mm ablation catheter and is indicated for use with the medtronic rf power generator to deliver rf energy for intracardiac ablation of accessory atrioventricular (av) conduction pathways associated with tachycardia for the treatment of av nodal re-entrant tachycardia and for creation of complete av block in patients with a difficult to control ventricular response to an atrial arrhythmia.
-
-