Prolog MP Pulse Generators 658K and 658T
by Pacesetter Systems 510(k)
Active
510(k) K872779
Overview
The Prolog MP Pulse Generators 658K and 658T are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class III medical devices, indicating they are high-risk and life-sustaining, and are intended for patients requiring chronic cardiac pacing support.
These pulse generators are supplied sterile and intended for single-use implantation, though they may be designed for long-term use within the body. They are regulated under FDA 510(k) clearance (K872779) and fall under the product code DXY, adhering to regulatory standards for implantable cardiac devices. No additional context regarding MRI safety, reusable components, or specific storage instructions is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872779 | Date4 Nov 1987 | 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- Withdrawn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 Prolog MP Pulse Generators 658K and 658T, and who would benefit from using them?
The Prolog MP Pulse Generators 658K and 658T are designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring chronic cardiac pacing support. These devices are intended for individuals with conditions that necessitate long-term pacing, such as bradycardia or other heart rhythm disorders, ensuring sustained cardiac function.
Are the Prolog MP Pulse Generators 658K and 658T intended for single-use or reusable implantation?
The Prolog MP Pulse Generators 658K and 658T are supplied sterile and intended for single-use implantation, though they are designed for long-term use within the body once implanted. This means they are not meant to be removed and reused, but rather remain implanted for the duration of their functional lifespan.
What regulatory pathway was followed for FDA clearance of these pulse generators, and what does that imply about their risk classification?
The Prolog MP Pulse Generators 658K and 658T were cleared through the FDA’s 510(k) process (with clearance number K872779) under the product code DXY. They are classified as Class III devices, which means they are considered high-risk and life-sustaining, requiring stringent regulatory oversight to ensure safety and efficacy for patients requiring chronic cardiac pacing.
Are there any specific storage instructions provided for these pulse generators, or should they be handled under standard sterile conditions?
The available data does not specify any unique storage instructions beyond the fact that these pulse generators are supplied sterile. As with all implantable medical devices, they should be stored in a clean, dry environment, protected from contamination, and handled using sterile techniques to maintain their integrity until implantation.