BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS
FDA premarket approval P000022/S004 · decided 2001-03-19
Approval details
- PMA number
- P000022
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2001-02-21
- Decision date
- 2001-03-19
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- OPTION TO USE AN AUTOMATED FILLING AND EVACUATING COATING CHAMBER, THAT THEN AUTOMATICALLY TRANSFERS THE CATHETERS TO THE CURING CHAMBER.
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