S670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
FDA premarket approval P970035/S039 · decided 2003-04-17
Approval details
- PMA number
- P970035
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- S670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2002-04-24
- Decision date
- 2003-04-17
- Days to decision
- 358 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL TO UPDATE THE LABELING OF THE S670 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS TO INCLUDE POST-PROCEDURE RESULTS FOR THE PREDICT STUDY POPULATION AND REMOVE REFERENCES TO THE EUROPEAN RACECAR STUDY.
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