• 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.
 
DevicePRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS156
Date Received02/20/2013
Decision Date05/08/2013
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A COLORANT CHANGE TO THE HUB PORTION OF THE INTRODUCER, ASURGICAL ACCESSORY FOR THE PRECISION SPINAL CORD STIMULATION SYSTEM THAT IS USED TO FACILITATE PLACEMENT OF A LEAD INTO THE EPIDURAL SPACE.
-
-