FDA 510(k) Application Details - K112214

Device Classification Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K112214
Device Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant	ST. JUDE MEDICAL NEUROMODULATION 6901 PRESTON RD. PLANO, TX 75024 US Other 510(k) Applications for this Company
Contact	PENNY HOUSTON Other 510(k) Applications for this Contact
Regulation Number	882.5880   More FDA Info for this Regulation Number
Classification Product Code	GZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2011
Decision Date	11/17/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review