• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 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 NameALTO DR MODEL 614, ALTO VR MODEL 615, ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS012
Date Received02/17/2004
Decision Date03/15/2004
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling to include a more accurate battery longevity data.
-
-