• 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

New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP990071
Date Received11/09/1999
Decision Date05/31/2000
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 03M-0045
Notice Date 03/01/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
The stockert 70 rf generator system is indicated for use with a biosense webster diagnostic/ablation deflectable tip catheter to deliver rf energy during cardiac ablation procedures.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S015 S016 S017 S018 S019 
S020 S022 S023 S024 S025 S027 S028 S029 S030 
S031 S032 S033