RAPID PROGRAMMAR


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K030118
Device Name RAPID PROGRAMMAR
Original Applicant
ADVANCED NEUROMODULATION SYSTEMS
6501 windcrest drive suite 100
plano, 
TX 
75024

Original Contact rashmi moza
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 01/13/2003
Decision Date 03/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No