Pacesetter/Siemens Pulse Genera W/Vs-1 Head Cavity
by Pacesetter Systems 510(k)
Active
510(k) K861422
Overview
This device is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is classified as a Class III medical device under FDA regulations, requiring a Premarket Approval (PMA) or 510(k) clearance for commercialisation. The device is intended for patients requiring artificial cardiac pacing to correct bradycardia or other rhythm disturbances.
The Pulse Genera with VS-1 Head Cavity is supplied as a reusable, implantable device and is intended for use in clinical settings such as hospitals or cardiac care units. It is not sterile at time of shipment but is intended to be sterilised prior to implantation. The device is MRI-unsafe and must be used with caution in patients requiring MRI scans. Authorised under FDA 510(k) clearance (K861422), it adheres to regulatory standards outlined in 21 CFR 870.3610 for implantable pacemakers.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861422 | Date26 Jun 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Pacesetter Systems
Questions
What is the primary purpose of the Pacesetter/Siemens Pulse Genera with VS-1 Head Cavity, and who is it intended for?
The Pulse Genera with VS-1 Head Cavity is an implantable pacemaker designed to regulate abnormal heart rhythms by delivering electrical impulses to correct bradycardia or other rhythm disturbances. It is intended for patients who require artificial cardiac pacing, typically in clinical settings like hospitals or cardiac care units.
Is this device single-use or reusable, and what are the sterilization requirements before implantation?
The Pulse Genera with VS-1 Head Cavity is a reusable device, intended for implantation in clinical settings. It is not sterile at shipment and must be sterilized prior to use, as specified in the manufacturer’s instructions.
Can this device be used safely in patients who require MRI scans, and why?
No, this device is MRI-unsafe and must be used with extreme caution in patients requiring MRI scans. The electrical components and materials used in implantable pacemakers can react unpredictably in strong magnetic fields, posing risks to both the patient and the device’s functionality.
What regulatory pathway was followed for this device’s commercialization, and what classification does it hold?
The Pulse Genera with VS-1 Head Cavity was authorized under an FDA 510(k) clearance (K861422) and is classified as a Class III medical device under FDA regulations. This classification requires a Premarket Approval (PMA) or 510(k) clearance before commercialization, reflecting its critical role in treating life-threatening cardiac conditions.
What types of facilities or settings are appropriate for using this device?
This device is intended for use in clinical settings such as hospitals or cardiac care units, where trained medical professionals can perform implantation, sterilization, and post-operative monitoring. Its reusable nature and specialized design require controlled environments to ensure proper handling and patient safety.