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 NameACTROS+ FAMILY OF PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator; pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS008
Date Received03/01/1999
Decision Date08/24/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) non-invasive programmed stimulation (nips) feature to be unlocked; 2) automatic sensor gain (asg) feature to be allowed in actros+ family; 3) release of programmer software version b-h02. 0. U; 4) change of trade name of pms 1000c programmer to epr 1000plus; and 5) use of the b-h02. 0. U pcmia software cartridge with tms1000 tachyarrhythmia monitoring system (p980023) as well as use of the b-h02. 0. U pcmia software cartridge in the epr 1000plus.
-
-