LEPTOS
Implantable Pacemaker Pulse-generator
BIOTRONIK SALES, INC.
The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Leptos.
Pre-market Notification Details
| Device ID | K841635 |
| 510k Number | K841635 |
| Device Name: | LEPTOS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | BIOTRONIK SALES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-19 |
| Decision Date | 1984-08-03 |
Trademark Results [LEPTOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEPTOS 77220841 3693151 Dead/Cancelled |
Leptos Biomedical, Inc. 2007-07-02 |
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