• 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 | 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEPIC HF FAMILY CRT-DS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS088
Date Received05/12/2008
Decision Date06/24/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for minor modifications and standardization of the ground connection, output flex, heat shield, and battery support for atla, atlas ii, convert, current, epic, epic ii, and promote crt-d and icd families.
-
-