Identity
- Trade Name
- MITRACLIP DELIVERY SYSTEM FDA PMA
- Generic Name
- Mitral valve repair devices FDA PMA
Identifiers
- PMA Number
- P100009 FDA PMA
- FDA Product Code
- NKM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The MitraClip G4 Clip Delivery System is a mitral valve repair device indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR). It is intended for patients determined to be at prohibitive risk for mitral valve surgery by a heart team, including a cardiac surgeon and cardiologist experienced in mitral valve disease.
The system is supplied as a delivery system for the MitraClip implant and is used in a hospital setting under the direction of a heart team. It is a single-use device, and its use is supported by FDA PMA approval (P100009). No information on sterility, MRI safety, sizes, or storage is provided in the data.
Frequently asked questions
What is the MitraClip G4 Clip Delivery System used for?
The MitraClip G4 Clip Delivery System is used for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus, specifically degenerative mitral regurgitation, in patients who are at prohibitive risk for mitral valve surgery as determined by a heart team.
Who manufactures the MitraClip G4 Clip Delivery System?
The MitraClip G4 Clip Delivery System is manufactured by Abbott Medical, as stated in the manufacturer and applicant fields of the device data.
Is the MitraClip G4 Clip Delivery System a single-use or reusable device?
The MitraClip G4 Clip Delivery System is a single-use device, as it is a delivery system designed for one-time implantation of the MitraClip clip and is not indicated for reuse in the provided specifications.
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 | P100009 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P100009 24 fields · synced Sep 18, 2026