Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- MULTI LINK RX ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM
- PMA Number
- P970020
- Supplement Number
- S042
- 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
- September 13, 2002
- Date Received
- March 19, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE MULTI-LINK RX AND OTW ZETA CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <= 35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. 3) RESTORING CORONARY FLOW IN PATIENTS EXPERIENCING ACUTE MYOCARDIAL INFARCTION, AS CONFIRMED BY ST SEGMENT ELEVATION OR ANGIOGRAPHIC FINDINGS, WHO PRESENT WITHIN 12 HOURS OF SYMPTOM ONSET WITH NATIVE CORONARY ARTERY LESIONS OF LENGTH <= MM WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM TO 4.0 MM. 4) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.5 MM TO 4.0 MM. LONG-TERM OUTCOME FOR THIS PERMANENT 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 |