BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
FDA premarket approval P000022/S001 · decided 2000-12-14
Approval details
- PMA number
- P000022
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2000-11-06
- Decision date
- 2000-12-14
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A CHANGE IN THE LABELING TO THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM. THE DEVICE IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYNPTOMATIC ISCHENIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS IMPLANT IS UNKNOWN AT PRESENT. THE RAPID EXCHANGE DELIVERY SYSTEM WILL A
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