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 | Infinity DBS IPG |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S074 |
Date Received | 10/22/2021 |
Decision Date | 11/16/2021 |
Product Codes |
MHY NHL PJS |
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 to 1) Adding an existing Abbott qualified supplier for diode components for 3 types of diodes; 2) Replacing tantalum decoupling capacitors with ceramic capacitors sourced from an existing Abbott qualified supplier; and 3) Reducing the number of tantalum output capacitors on the EPPIC charge pump. |
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