Synthemed Pulse Generator VVI Model 1000
by Synthemed Corp. 510(k)
Active
510(k) K812464
Overview
The Synthemed Pulse Generator VVI Model 1000 is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It operates in a VVI (Ventricular-Inhibited Ventricular) mode, ensuring synchronized pacing to maintain proper heart function in patients with bradycardia or conduction disorders.
This device is intended for implantable use within the cardiovascular system and is classified as a Class III medical device, reflecting its high-risk, life-sustaining nature. Supplied sterile and intended for single-use implantation, it adheres to FDA 510(k) clearance (K812464) under the Traditional pathway, with regulatory oversight under 870.3610. Storage and handling must comply with sterile medical device protocols to ensure proper functionality and patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812464 | Date16 Nov 1981 | 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- Withdrawn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 Synthemed Corp.
Questions
What is the primary purpose of the Synthemed Pulse Generator VVI Model 1000 and how does it function in the body?
The Synthemed Pulse Generator VVI Model 1000 is an implantable pacemaker designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It operates in VVI (Ventricular-Inhibited Ventricular) mode, which means it paces the ventricles only when the heart’s natural rhythm falls below a preset rate, ensuring synchronized pacing to maintain proper heart function in patients with bradycardia or conduction disorders.
Is the Synthemed Pulse Generator VVI Model 1000 intended for reuse or single-use, and how should it be handled?
The device is supplied sterile and intended for single-use implantation only. Due to its sterile packaging and high-risk, life-sustaining nature, it must be handled according to sterile medical device protocols to preserve functionality and ensure patient safety.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?
The Synthemed Pulse Generator VVI Model 1000 received FDA clearance under the Traditional 510(k) pathway (K812464) and was determined to be substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device.
What storage and handling requirements apply to this device to maintain its sterility and performance?
Since the device is sterile upon packaging, it must be stored and handled in accordance with standard sterile medical device protocols. This includes keeping it in its original, unopened packaging until immediate use and avoiding exposure to contamination or environmental stressors that could compromise its integrity.