Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM
- PMA Number
- P000011
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 26, 2002
- Date Received
- February 1, 2002
- Supplement Type
- Normal 180 Day Track
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF THE 7 MM STENT LENGTH (IN ALL DIAMETERS, 2.0, 2.25 AND 2.5 MM) AND 2.25 MM DIAMETER BIODIVYSIO SV OTW PRODUCT TO PREVIOUSLY APPROVED STENT LENGTHS OF 10, 15 AND 18 MM (SUPPLEMENT 3). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO SV OTW AND IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS EXPERIENCING ABRUPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH REFERENCE VESSEL DIAMETER RANGING FROM >=2.0 MM TO <=2.75 MM BY VISUAL ESTIMATE. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT.
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 |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |