• 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 | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
399 jefferson road
parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS039
Date Received10/17/1996
Decision Date07/17/1997
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R)-2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line.