DRIVER CORONARY STENT SYSTEMS
FDA premarket approval P030009/S034 · decided 2009-04-07
Approval details
- PMA number
- P030009
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DRIVER CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2009-03-23
- Decision date
- 2009-04-07
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- REMOVAL OF DUPLICATE VISUAL INSPECTION ON THE PACKAGING.
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