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 | WaveWriter Alpha, WaveWriter Alpha 16 |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P030017 |
Supplement Number | S350 |
Date Received | 06/13/2022 |
Decision Date | 06/23/2022 |
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 Changes to update the Laser Excise process by adding a pre-excise phase, modifying the laser focal point, and shifting the position of the laser closer to the excised edge during the ablation phase during the manufacturing of the Printed Circuit Board assembly (PCBA) of the Implantable Pulse Generator (IPG) at the Boston Scientific Clonmel manufacturing site. |
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