MICRO-DRIVER CORONARY STENT SYSTEM (MX2 & OTW)
FDA premarket approval P030009/S014 · decided 2007-08-30
Approval details
- PMA number
- P030009
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICRO-DRIVER CORONARY STENT SYSTEM (MX2 & OTW)
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2007-08-01
- Decision date
- 2007-08-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGE TO THE FORM TOOL EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICE.
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