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

510(k) Premarket Notification
  • 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
Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K063080
Device Name TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
Applicant
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact AMY CLENDENING
Correspondent
Advanced Neuromodulation Systems
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact AMY CLENDENING
Regulation Number882.5880
Classification Product Code
GZB  
Date Received10/10/2006
Decision Date 12/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-