Identity
- Trade Name
- DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS FDA PMA
- Generic Name
- implantable pacemaker Pulse-generator FDA PMA
Identifiers
- PMA Number
- P950037 FDA PMA
- FDA Product Code
- DXY FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.3610 FDA PMA
- Regulation Number
- 870.3610 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Home Monitoring System Version 3.48 is an implantable pacemaker pulse-generator system designed for rate-adaptive pacing. It is indicated for patients exhibiting chronotropic incompetence who would benefit from increased pacing rates concurrent with physical activity, as used with the Dromos DR and Dromos SR pulse generators.
This system is supplied as part of the Dromos DR/DR-A and Dromos SR/SR-B cardiac pacing systems. It received FDA PMA approval (P950037) on October 11, 1996, and is classified as a Class III implantable pacemaker pulse-generator under regulation 870.3610 for cardiovascular use.
Frequently asked questions
What is the Home Monitoring System Version 3.48 used for?
The Home Monitoring System Version 3.48 is used for rate-adaptive pacing in patients with chronotropic incompetence who would benefit from increased pacing rates during physical activity, as specified in the AO statement for use with Dromos DR and Dromos SR pulse generators.
Who manufactures the Home Monitoring System Version 3.48 and what regulatory pathway was used?
The Home Monitoring System Version 3.48 is manufactured by Biotronik, Inc., and received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P950037 granted on October 11, 1996.
What type of device is the Home Monitoring System Version 3.48 classified as?
The Home Monitoring System Version 3.48 is classified as an implantable pacemaker pulse-generator, which is a Class III medical device under FDA regulation 870.3610 for cardiovascular applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P950037 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA PMA P950037 24 fields · synced Sep 18, 2026