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.
 
DeviceSTAT-PACE II ESOPHAGEAL PACING SYSTEM
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardiocommand, Inc.
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP840002
Supplement NumberS009
Date Received01/21/1997
Decision Date09/03/1997
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design and labeling modification to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems.
-
-