Programmalith Ii, #225 & 226
by Pacesetter Systems 510(k)
Active
510(k) K821003
Overview
The Programmalith II, Models 225 & 226, is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm in patients with bradycardia or conduction system disorders. This device delivers electrical impulses to stimulate the heart muscle, ensuring consistent and appropriate heart contractions when the natural pacemaker fails.
These pulse-generators are intended for surgical implantation and are classified as Class III medical devices under FDA regulations. Supplied sterile and intended for single-use, they require proper handling and storage as per manufacturer guidelines. The devices are authorized under FDA 510(k) clearance (K821003) and fall under the regulation number 870.3610, adhering to strict cardiovascular device standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821003 | Date7 May 1982 | 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- Withdrawn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 clinical purpose of the Programmalith II, Models 225 & 226, and which patient conditions does it address?
The Programmalith II, Models 225 & 226, is designed to regulate cardiac rhythm by delivering electrical impulses to stimulate the heart muscle. It is specifically intended for patients with bradycardia (slow heart rate) or conduction system disorders where the heart’s natural pacemaker is not functioning properly.
Are these devices meant for single-use or can they be reused after implantation?
The Programmalith II, Models 225 & 226, are supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as this could compromise sterility and patient safety.
How should these devices be stored to maintain their integrity before use?
Since these pulse-generators are sterile and single-use, they must be stored according to the manufacturer’s guidelines to preserve sterility. This typically includes keeping them in their original packaging, in a clean, dry environment, and away from extreme temperatures or direct sunlight until implantation.
What regulatory pathway was followed for FDA clearance of the Programmalith II, and which committee reviewed it?
The Programmalith II, Models 225 & 226, received FDA clearance through a Traditional 510(k) pathway (K821003) and was reviewed by the Cardiovascular (CV) Advisory Committee. The device is classified as a Class III medical device under FDA regulations, adhering to the specific standards outlined in regulation number 870.3610.