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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 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 NameREPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS054
Date Received07/19/2010
Decision Date08/18/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a reinforced inspection step to the manufacturing process of the device.
-
-