Microlith A Model 803 Implantable Pacemaker Pulse-Generator
510(k) K782023
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782023 | Date22 Dec 1978 | 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- Withdrawn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
- Full name
- Microlith a Model 803
- 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 Microlith A Model 803 is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing. As classified under FDA regulation 870.3610, this device is implanted subcutaneously and functions as the power source and control unit for pacing electrodes.
This device is supplied sterile and intended for single-use implantation, though it may be reprogrammable post-implantation. It is not MRI-compatible and must be used in sterile surgical settings. The Model 803 is authorized under an FDA 510(k) clearance (K782023) and falls under the product code DXY, with advisory committee review by the Cardiovascular (CV) panel. Storage and handling must comply with sterile medical device protocols to ensure functionality and patient safety.
Other devices from Cardiac Pacemakers, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Microlith A Model 803 pacemaker, and how does it function in the body?
The Microlith A Model 803 is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the patient’s natural heartbeat is too slow (bradycardia) or irregular due to conduction disorders. It acts as the power source and control unit for pacing electrodes, implanted subcutaneously to ensure consistent pacing support for chronic cardiac needs.
Is the Microlith A Model 803 intended for reuse, or is it meant to be used only once after implantation?
The device is supplied sterile and intended for single-use implantation. While it may be reprogrammable post-implantation to adjust pacing parameters, it is not designed for reuse or removal and replacement in the same patient.
What storage and handling precautions must be taken with the Microlith A Model 803 to maintain its sterility and functionality?
The device must be stored and handled according to sterile medical device protocols, as it is supplied sterile and intended for surgical implantation. Proper storage ensures functionality and patient safety, and it must only be used in sterile surgical settings.
Can the Microlith A Model 803 be used in patients who require MRI scans, or does it have any MRI-related restrictions?
The device is not MRI-compatible, meaning it should not be used in patients who require MRI scans. This restriction is due to potential risks from electromagnetic interference during MRI procedures.
What regulatory pathway was followed for the FDA clearance of the Microlith A Model 803, and which advisory committee reviewed it?
The Microlith A Model 803 received FDA clearance through a Traditional 510(k) pathway (K782023) and was reviewed by the Cardiovascular (CV) Advisory Committee. The device was classified as substantially equivalent to a predicate under FDA regulation 870.3610.