• 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 NameSELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS038
Date Received05/27/2004
Decision Date11/10/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a drug collar to the pacing lead. The device, as modified, will be marketed under the trade name selox st/jt and is indicated as follows: selox st and selox jt steroid eluting leads are designed for use with implantable pulse generators that require pacing leads with a bipolar 3. 2 mm is-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the class i definition of the acc/aha/naspe task force report, entitled "acc/aha/naspe 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the american college of cardiology/american heart association task force on practice guidelines (acc/aha/naspe committee on pacemaker implantation)" (gregoratos et al. 2002).
-
-