Transcatheter Septal Occluder
Basic Information
- Device Name
- Transcatheter Septal Occluder
- Trade Name
- CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
- PMA Number
- P000049
- Device Class
- FDA Class 3
- Product Code
- MLV
- Generic Name
- Transcatheter septal occluder
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 5, 2001
- Date Received
- November 21, 2000
- Expedited Review
- N
- Docket Number
- 02M-0272
Advisory Committee Statement
APPROVAL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD. THE SYSTEM IS INDICATED FOR USE IN PATIENTS WITH COMPLEX VENTRICULAR SEPTAL DEFECTS (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION. HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS: 1) REQUIRING A LEFT VENTRICULOTOMY OR AN EXTENSIVE RIGHT VENTRICULOTOMY; 2) WITH A FAILED PREVIOUS VSD CLOSURE; 3) WITH MULTIPLE APICAL AND/OR ANTERIOR MUSCULAR VSDS ("SWISS CHEESE SEPTUM"); OR 4) WITH POSTERIOR APICAL VSDS COVERED BY TRABECULAE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLV | Transcatheter Septal Occluder | FDA class 3 | Unknown |