|
Device | GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S094 |
Date Received | 12/24/2014 |
Decision Date | 03/24/2015 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES TO THE 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2321 AND 2326) FOR THE SPINAL CORD STIMULATION SYSTEM. THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL BOSTON SCIENTIFIC LEAD OR EXTENSION TO A COMPATIBLE ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR. |