A127 LEAD EXTENSION


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K030461
Device Name A127 LEAD EXTENSION
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6501 windcrest drive suite 100
plano, 
TX 
75024

Applicant Contact rashmi moza
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6501 windcrest drive suite 100
plano, 
TX 
75024

Correspodent Contact rashmi moza
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 02/12/2003
Decision Date 04/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No