ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
FDA premarket approval P110011/S007 · decided 2014-04-17
Approval details
- PMA number
- P110011
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic, Ireland
- Date received
- 2014-03-18
- Decision date
- 2014-04-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.
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