LAMITRODE S-SERIES (S4 AND S8) LEADS


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K022222
Device Name LAMITRODE S-SERIES (S4 AND S8) LEADS
Original Applicant
ADVANCED NEUROMODULATION SYSTEM,INC
6501 windcrest drive,sute 100
plano, 
TX 
75024

Original Contact katryna warren
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 07/09/2002
Decision Date 08/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No