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S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM

FDA premarket approval P970035/S029 · decided 2001-10-04

Approval details

PMA number
P970035
Supplement
S029
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronic, Ireland
Date received
2001-08-14
Decision date
2001-10-04
Days to decision
51 days
Decision code
APPR
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS USING THE AV100 BALLOON MATERIAL. (NOTE THAT ALTHOUGH THIS MATERIAL WAS INCLUDED IN PRODUCT USED IN THE CLINICAL TRIAL REPORTED IN SUPPLEMENT 22, APPROVAL WAS ONLY SOUGHT AND GRANTED FOR THE AV2000 BALLOON MATERIAL.)

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