Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Proclaim Elite 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 | S140 |
Date Received | 12/18/2017 |
Decision Date | 01/10/2018 |
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 Alternate supplier manufacturing location for the drilling process for the Bluetooth (BLE) antenna (this also included new equipment models). The BLE antenna is a component of the spinal cord stimulation (SCS) and deep brain stimulation (DBS) implantable pulse generator (IPGs) headers. |
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