RENEW LEAD EXTENSION


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K991784
Device Name RENEW LEAD EXTENSION
Applicant
ADVANCED NEUROMODULATION SYSTEMS
one allentown pkwy.
allen, 
TX 
75002

Applicant Contact katryna warren
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
one allentown pkwy.
allen, 
TX 
75002

Correspodent Contact katryna warren
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 05/25/1999
Decision Date 06/24/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No