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Device | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S175 |
Date Received | 05/10/2021 |
Decision Date | 06/08/2021 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacement of the current MSP430 microcontroller chip on the implantable pulse generator's printed circuit board with an MSP430 chip with updated packaging. |