Ovatio Vr/Dr
PMA P980049
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP980049 | Date15 Sep 1999 | StatusActive |
Recalls
-
- Terminated Z-3232-2017
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
-
- Terminated Z-3231-2017
- Terminated Z-3229-2017
- Terminated Z-3228-2017
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Defender II Model 9201 Implantable Cardioverter Defibrillator
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- FDA applicant
- MicroPort CRM S.r.l.
- PMA Number
- FDA Product Code
- MRM
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Ovatio VR/DR is an implantable, dual-chamber defibrillator designed to prevent sudden death in patients at risk of ventricular arrhythmias. It monitors and treats life-threatening ventricular tachyarrhythmias, including sustained ventricular tachycardia and cardiac arrest due to ventricular tachyarrhythmia, through synchronized cardioversion and defibrillation.
This device is implanted subcutaneously and is intended for single-use implantation with long-term monitoring capabilities. Supplied sterile and packaged for surgical use, it requires surgical implantation by a qualified healthcare professional. Authorized under FDA PMA (P980049), it adheres to Class III regulatory standards and is categorized under product code MRM.
Other devices from MicroPort CRM USA, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of patients is the Ovatio VR/DR intended to protect from sudden cardiac death?
The Ovatio VR/DR is designed for patients at high risk of sudden death due to ventricular arrhythmias, specifically those who have either survived at least one episode of cardiac arrest caused by a ventricular tachyarrhythmia (including loss of consciousness) or experienced recurrent, poorly tolerated sustained ventricular tachycardia (VT). It is not intended for patients without these specific risk factors.
Is the Ovatio VR/DR meant to be reused after implantation, or is it a single-use device?
The Ovatio VR/DR is explicitly intended for single-use implantation—it is not designed for removal or reuse. Once implanted, it remains in place for long-term monitoring and treatment of life-threatening arrhythmias, requiring no further intervention beyond routine follow-up.
How is the Ovatio VR/DR supplied, and what precautions should be taken during handling?
The device is supplied sterile and pre-packaged for surgical use, ensuring it meets clinical sterility standards before implantation. Since it is implanted subcutaneously by a qualified healthcare professional, proper sterile technique must be maintained during the surgical procedure to prevent infection.
What regulatory pathway was followed for the Ovatio VR/DR’s approval, and what does that mean for its use?
The Ovatio VR/DR was authorized under the FDA Premarket Approval (PMA) process (PMA #P980049), which is the highest level of regulatory review for Class III devices. This means the device underwent rigorous clinical testing to demonstrate safety and effectiveness before approval, ensuring it meets strict standards for preventing sudden cardiac death in eligible patients.