BESTENT (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
FDA premarket approval P000022/S007 · decided 2001-09-26
Approval details
- PMA number
- P000022
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BESTENT (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2001-08-20
- Decision date
- 2001-09-26
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AMENDING THE TEST OF THE BESTENT 2 POST-APPROVAL STUDY PROTOCOL TO REFLECT ADMINISTRATIVE UPDATES.
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