Stratos, Evia, & Entovis Families Of Crt-P's
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD FDA PMA
- Generic Name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) FDA PMA
Identifiers
- PMA Number
- P070008 FDA PMA
- FDA Product Code
- NKE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Stratos LV CRT-P and Stratos LV-T CRT-P are implantable cardiac resynchronization therapy-pacing (CRT-P) pulse generators designed for patients with moderate to severe heart failure. These devices incorporate bipolar steroid-eluting leads (Corox OTW BP and Corox OTW-S BP) intended for permanent implantation in the left ventricle via coronary veins to deliver pacing and sensing functions.
The system is supplied as a combination of pulse generators and leads, intended for use in conjunction with compatible IS-1 pulse generators. The Corox OTW BP and Corox OTW-S BP leads are reusable and require sterile preparation prior to implantation. Approved under FDA PMA (P070008), these devices are classified as Class III medical devices under the OpenFDA nomenclature, adhering to strict regulatory standards for cardiac resynchronization therapy.
Frequently asked questions
What types of patients is the Stratos CRT-P system approved for use in, and what clinical criteria define their eligibility?
The Stratos LV CRT-P and Stratos LV-T CRT-P systems are approved for patients with moderate to severe heart failure (NYHA Class II-IV) who have left ventricular dysfunction (ejection fraction less than 35%) and a prolonged QRS duration greater than 120 milliseconds. These patients must remain symptomatic despite stable, optimized heart failure drug therapy, as outlined in the FDA PMA approval (P070008).
Are the leads included in the Stratos CRT-P system reusable, and if so, what preparation is required before implantation?
Yes, the Corox OTW BP and Corox OTW-S BP leads in the Stratos CRT-P system are reusable. However, they require sterile preparation prior to implantation to ensure proper surgical conditions, as specified in the device description.
How is the Stratos CRT-P system supplied, and what other components must be used with it?
The Stratos CRT-P system is supplied as a combination of pulse generators (Stratos LV CRT-P and Stratos LV-T CRT-P) and the Corox OTW BP or Corox OTW-S BP leads. These devices are intended for use in conjunction with compatible IS-1 pulse generators, as noted in the product description.
What regulatory pathway was followed for the approval of the Stratos CRT-P system, and what classification does it hold?
The Stratos LV CRT-P and Stratos LV-T CRT-P systems were approved via the FDA Premarket Approval (PMA) process under PMA number P070008. These devices are classified as Class III medical devices under the OpenFDA nomenclature, adhering to strict regulatory standards for cardiac resynchronization therapy.
What is the primary purpose of the Corox OTW BP and Corox OTW-S BP leads in the Stratos CRT-P system?
The Corox OTW BP and Corox OTW-S BP leads are bipolar steroid-eluting leads designed for permanent implantation in the left ventricle via coronary veins. Their purpose is to deliver pacing and sensing functions when used with a compatible IS-1 pulse generator, helping to synchronize heart contractions for patients with moderate to severe heart failure.
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 | P070008 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA PMA P070008 24 fields · synced Oct 6, 2026