Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement
by Medtronic Ats Medical, Inc.
PMA P990046
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP990046 | Date13 Oct 2000 | StatusActive |
Recalls
-
- Terminated Z-1533-2020
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
-
- Terminated Z-0634-04
Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Ats Open Pivot Bileaflet Heart Valve
- Generic Name
- HEART-VALVE, MECHANICAL
- PMA Number
- FDA Product Code
- LWQ
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Laser Angle Measurement Tool is a diagnostic device designed to measure leaflet angles during the opening and closing phases of bileaflet mechanical heart valves. It aids in assessing valve function and alignment, ensuring proper performance of the ATS Open Pivot Bileaflet Heart Valve in both aortic and mitral positions.
This tool is intended for use in clinical settings, typically during surgical or catheter-based procedures involving heart valve replacement. Supplied as a reusable instrument, it is not sterile and requires appropriate cleaning and maintenance between uses. The device is regulated under FDA PMA approval (PMA P990046) and is associated with specific valve models, including Standard Aortic (A500FA 21–29 mm), Standard Mitral (500DM 29–33 mm), and Advanced Performance (AP) variants (501DA 18–26 mm; 510DM 26–28 mm).
Questions
AI-generated answers, 18 Sep 2026
What specific heart valve models is the Laser Angle Measurement Tool designed to work with during angle measurements?
The Laser Angle Measurement Tool is designed to measure leaflet angles for the ATS Open Pivot Bileaflet Heart Valve, specifically for the Standard Aortic models (A500FA, sizes 21–29 mm), Standard Mitral models (500DM, sizes 29–33 mm), and Advanced Performance (AP) variants (501DA, sizes 18–26 mm for aortic; 510DM, sizes 26–28 mm for mitral). It aids in assessing valve function and alignment during surgical or catheter-based procedures.
Is the Laser Angle Measurement Tool intended for single-use or can it be reused after proper cleaning?
The Laser Angle Measurement Tool is supplied as a reusable instrument. Since it is not sterile out-of-the-box, it requires appropriate cleaning and maintenance between uses to ensure accuracy and safety in clinical settings.
What types of procedures is this tool typically used in, and where would it be most applicable?
This tool is intended for use in clinical settings during surgical or catheter-based procedures involving heart valve replacement, specifically for bileaflet mechanical heart valves in aortic or mitral positions. It helps evaluate leaflet angles during the opening and closing phases to ensure proper valve function and alignment.
How is the regulatory approval status of this device, and what does that mean for its use?
The Laser Angle Measurement Tool is regulated under FDA PMA approval (PMA P990046), meaning it has undergone a rigorous premarket approval process to demonstrate safety and effectiveness. This approval is tied to its use with the ATS Open Pivot Bileaflet Heart Valve and does not imply broader indications beyond those specified in the device description.