| 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 | Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application |
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| Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
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| Applicant | ABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024 |
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| PMA Number | P140009 |
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| Supplement Number | S087 |
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| Date Received | 07/28/2023 |
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| Decision Date | 01/24/2024 |
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| Product Codes |
MHY NHL PJS |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
For P140009/S087, approval for:• The Liberta RCTM DBS System, including the Liberta RC DBS IPG (model 62400) and Charger Kit – Pectoral (model 66000)• Patient Controller Application version 2.0 and Clinician Programmer Application version 2.0 including the NeuroshpereTM Virtual Clinic • Alternate resistor component changes in the printed circuit board assembly (PCBA) for the Liberta RC DBS IPG (model 62400)• An alternate cell battery part number from an existing supplier for Charger Model 16000 when used with the Liberta RC DBS SystemFor P010032/S202, approval for:• Patient Controller Application version 2.0 and Clinician Programmer Application version 2.0 including the NeuroshpereTM Virtual Clinic and FlexBurst360TM programming• Change the requirement regarding MRI mode during charging in the Eterna SCS System to align with the Liberta RC DBS System |
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