• 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 NameREPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
ApplicantSORIN GROUP- CRM
PMA NumberP950029
Supplement NumberS097
Date Received10/01/2014
Decision Date10/23/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the implant manuals in alignment with a previous safety communication.
-
-