Implantable Pacemaker Pulse-Generator — Biotronik, Inc. (PMA P950037)
Implantable Pacemaker Pulse-Generator — Biotronik, Inc. (PMA P950037) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Implantable Pacemaker Pulse-Generator; Applicant: Biotronik, Inc.; Clearance track: PMA.
| Device name | Implantable Pacemaker Pulse-Generator |
|---|---|
| Applicant | Biotronik, Inc. |
| Clearance track | PMA |
| Submission number | P950037 |
| Decision | APPR |
| Decision date | 2022-12-02 |
| Date received | 2022-09-26 |
| Product code | DXY |
| Device class | 3 |
| Medical specialty | Cardiovascular |
| Applicant location | OR |
| Source | openFDA device |
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$1999/mo
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