|
Device | Proclaim Elite family of SCS IPGs |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S134 |
Date Received | 09/11/2017 |
Decision Date | 12/09/2017 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for updated versions of the Clinician Programmer and Patient Controller software (v 3.6) that include new methods for calculating battery status and recovering system functions after exposure to power disturbances. |