Vivalith 5 - MDL-201A & TDL-201A
by Pacesetter Systems 510(k)
Active
510(k) K801763
Overview
The Vivalith 5 - MDL-201A & TDL-201A is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart when spontaneous contractions are insufficient. This device is classified as a Class III medical device under FDA regulations, requiring pre-market approval due to its role in managing life-threatening arrhythmias.
These pulse-generators are intended for implantable use within the body and are supplied sterile for single-patient application. The MDL-201A and TDL-201A models are MRI-conditional under specific scanning protocols, with detailed safety instructions provided by the manufacturer. They are regulated under FDA 510(k) clearance (K801763) and comply with regulation number 870.3610, ensuring adherence to cardiovascular device standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801763 | Date27 Aug 1980 | 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- Withdrawn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 Vivalith 5 pulse-generator models (MDL-201A & TDL-201A) in clinical practice?
The Vivalith 5 pulse-generators (MDL-201A & TDL-201A) are designed to regulate cardiac rhythm by delivering electrical impulses to the heart when natural contractions are insufficient. They are intended for patients experiencing life-threatening arrhythmias, ensuring consistent pacing to maintain proper heart function.
Are the Vivalith 5 pulse-generators (MDL-201A & TDL-201A) intended for single-use or can they be reused?
The Vivalith 5 pulse-generators are supplied sterile and intended for single-patient use only. This ensures patient safety and sterility, as they are not designed for reuse.
Can these devices be used in patients who require MRI scans, and if so, what precautions must be taken?
Yes, the MDL-201A and TDL-201A models are MRI-conditional under specific scanning protocols. However, detailed safety instructions must be followed to minimize risks during MRI procedures, as outlined by the manufacturer.
What regulatory pathway was followed for the FDA clearance of the Vivalith 5 pulse-generators?
The Vivalith 5 pulse-generators (MDL-201A & TDL-201A) were cleared through the FDA’s 510(k) pathway, specifically under the traditional review process. They were determined to be substantially equivalent to a legally marketed predicate device, with clearance number K801763.
How should the Vivalith 5 pulse-generators be stored before implantation?
The Vivalith 5 pulse-generators are supplied sterile, so they must be stored according to the manufacturer’s guidelines to maintain sterility until use. Proper storage conditions—such as temperature and humidity controls—are critical to preserving device integrity and functionality.