• 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 NameR5.111WE(REVISION OF R5.85WE)
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemakers
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP900070
Supplement NumberS025
Date Received09/07/1999
Decision Date09/24/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the version r5. 111we programmer software for the model 9602 programmer.
-
-