DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS
FDA premarket approval P030009/S050 · decided 2011-04-12
Approval details
- PMA number
- P030009
- Supplement
- S050
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2010-11-15
- Decision date
- 2011-04-12
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.
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