| 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. |
| |
| Device | Deep Brain Stimulation (DBS) |
|---|
| Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
|---|
| Applicant | ABBOTT MEDICAL
6901 Prestion Rd.
Plano, TX 75024 |
|---|
| PMA Number | P140009 |
|---|
| Supplement Number | S067 |
|---|
| Date Received | 02/12/2021 |
|---|
| Decision Date | 07/26/2021 |
|---|
| 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 |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
Approval for the replacement of the supplier for the Thermal Cutoff (TCO) component used in the lithium ion (Li-Ion) Rechargeable Battery Pack used to recharge Implanted Pulse Generator (IPG), and for a design change to the TCO component of the Battery Pack. The design change includes the addition of a bottom metal strap to the TCO component, different dimensions of the Battery Pack due to the thicker new TCO component, an increased current allowance from 2 Amps to 7 Amps, lower voltage cutoff from 32 Volts to 28 Volts, and a lower temperature cutoff of from 92C to 82C. This change is implemented to the following specific Chargers: 3720 Eon Mini LE Charger, 3722 Eon Mini LE Charging System, 3727 Eon Charger, 3726 Eon Charging System, 3730 Prodigy Charging System, 6720 Brio LE Charger, 6722 Brio LE Charging System. |
|
|
