Maestro Series 500 P.G.& Model 1006 Pacemaker Prog
by Cardiac Control Systems, Inc.
PMA P860027
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP860027 | Date27 Feb 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Maestro Series 500 P.G. Models 501, 505, 509
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- PMA Number
- FDA Product Code
- LWP
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Maestro Series 500 P.G. Model 1006 is an implantable pulse generator pacemaker (non-CRT), designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is classified as a Class III medical device under FDA regulations and is intended for use in patients requiring cardiac pacing support.
This programmer is used in clinical settings to adjust and monitor the settings of implanted pacemakers, ensuring proper function and patient response. Supplied as a reusable device, it is regulated under an FDA Premarket Approval (PMA) with the designation P860027. The device adheres to the product code LWP and is intended for use with compatible pacemaker models, though no specific sterility or MRI safety information is provided in the data.
Other devices from Cardiac Control Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the purpose of the Maestro Series 500 P.G. Model 1006 pacemaker programmer?
The Maestro Series 500 P.G. Model 1006 is a reusable device used in clinical settings to adjust and monitor settings of implanted pacemakers, ensuring proper function and patient response.
Is the Maestro Series 500 P.G. Model 1006 a single-use device?
No, the Maestro Series 500 P.G. Model 1006 is supplied as a reusable device designed for multiple clinical applications.
What regulatory approval does the Maestro Series 500 P.G. Model 1006 have?
The device has FDA Premarket Approval (PMA) with designation P860027 and is classified as a Class III medical device under FDA regulations.
What pacemaker models is the Maestro Series 500 P.G. Model 1006 compatible with?
The programmer is intended for use with compatible pacemaker models, though specific compatible models are not listed in the provided data.