• 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 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 Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecardiac ablation catheter
PMA NumberP050024
Date Received07/15/2005
Decision Date08/01/2007
Withdrawal Date 07/29/2008
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 07M-0303
Notice Date 08/03/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cryocor cryoablation system. The device is indicated for use in the ablation of isthmus-dependent right atrial flutter in patients 18 years of age or older.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001