LAMITRODE SPINAL CORD STIMULATION LEADS

Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K033429
Device Name LAMITRODE SPINAL CORD STIMULATION LEADS
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6501 windcrest drive suite 100
plano, 
TX 
75024

Applicant Contact danielle alarcon
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6501 windcrest drive suite 100
plano, 
TX 
75024

Correspodent Contact danielle alarcon
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 10/28/2003
Decision Date 12/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No