DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS
FDA premarket approval P030009/S028 · decided 2008-12-24
Approval details
- PMA number
- P030009
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2008-11-05
- Decision date
- 2008-12-24
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM.
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