Identity
- Trade Name
- AMPLATZER MUSCULAR VSD OCCLUDER FDA PMA
- Generic Name
- Transcatheter septal occluder FDA PMA
Identifiers
- PMA Number
- P040040 FDA PMA
- FDA Product Code
- MLV FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Amplatzer Muscular VSD Occluder is a transcatheter septal occluder designed for percutaneous closure of muscular ventricular septal defects (VSDs). It is intended for use in patients with complex VSDs of significant size, including those with large left-to-right shunts, pulmonary hypertension, or symptomatic congestive heart failure, who are deemed high-risk for traditional surgical closure due to anatomical or medical factors.
This device is delivered via catheterization and deployed within the heart to occlude abnormal openings in the muscular ventricular septum. Supplied sterile and intended for single-use, it is classified as a Class III medical device under FDA regulations. Available in multiple sizes, it requires specialized cardiac catheterization facilities and trained personnel for implantation, adhering to strict sterility and handling protocols. Authorization for use is granted under FDA PMA approval (P040040)
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 | P040040 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P040040 24 fields · synced Sep 18, 2026