Device Classification Name |
stimulator, spinal-cord, implanted (pain relief)
|
510(k) Number |
K123299 |
Device Name |
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS |
Applicant |
ST. JUDE MEDICAL NEUROMODULATION |
6901 PRESTON RD. |
PLANO,
TX
75024
|
|
Applicant Contact |
TERRINA WILDER, RAC |
Correspondent |
ST. JUDE MEDICAL NEUROMODULATION |
6901 PRESTON RD. |
PLANO,
TX
75024
|
|
Correspondent Contact |
TERRINA WILDER, RAC |
Regulation Number | 882.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/23/2012 |
Decision Date | 01/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|