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.
 
DeviceST.JUDE MEDICAL ICDS/CRT-D
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS080
Date Received07/29/2005
Decision Date12/16/2005
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ELIMINATION OF AN EXTRA LAYER OF PARYLENE COATING THAT IS APPLIED OVER THE HIGH VOLTAGE CAPACITOR PRIOR TO ITS INSTALLATION INTO THE DEVICE ASSEMBLY DURING THE ICD/CRT-D MANUFACTURING.
-
-