Optima Mdt Pulse Generator W/Telemetry
510(k) K833798
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833798 | Date1 Dec 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Optima MDT Pulse Generator with Telemetry is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients requiring pacing support due to bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function through programmable pacing modes and telemetry capabilities for remote monitoring.
This device is supplied sterile and intended for single-use implantation, though it may be reprogrammable post-implantation. It is classified as Class III under FDA regulations (DXY product code, 870.3610) and was granted FDA 510(k) clearance under a Traditional pathway, with a Substantially Equivalent determination by the Cardiovascular (CV) Advisory Committee. Compatibility with MRI is not specified, and storage conditions must adhere to manufacturer guidelines to maintain sterility and functionality.