• 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 | 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.
Classification Namestimulator, invasive bone growth
Generic Namesdpf implantable spinal fusion stimulator
ApplicantEBI, L.P.
PMA NumberP850035
Supplement NumberS028
Date Received05/30/2000
Decision Date06/23/2000
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from a lithium iodine battery (crc 1935m) to a lithium manganese battery (renata, cr-2032amt207-1) in the spf(r) 2t, 4t and xliib spinal fusion stimulators.