DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS
FDA premarket approval P970035/S041 · decided 2002-12-06
Approval details
- PMA number
- P970035
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2002-08-05
- Decision date
- 2002-12-06
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL TO MODIFY THE LABELING FOR THE MEDTRONIC AVE S660, S670 & S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS TO REFLECT A MINIMUM GUIDE CATHETER INNER DIAMETER OF 0.056".
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