BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS
FDA premarket approval P000022/S006 · decided 2001-06-05
Approval details
- PMA number
- P000022
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2001-04-16
- Decision date
- 2001-06-05
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE UPDATED LABELING FOR THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE AND OVER-THE-WIRE CORONARY STENT DELIVERY SYSTEMS.
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