Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
Generic NameSystem, pacing, temporary, acute, internal atrial defibrillation
ApplicantSt. Jude Medical
14901 DEVEAU PLACE
MINNEAPOLIS, MN 55345-2126
PMA NumberP020052
Supplement NumberS004
Date Received08/24/2007
Decision Date09/21/2007
Withdrawal Date 04/17/2015
Product Code MTE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATION OF THE METHOD OF TRAY CLEANING USED IN PACKAGING OF THE DEVICE.
-
-