ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
FDA premarket approval P110011/S013 · decided 2017-02-01
Approval details
- PMA number
- P110011
- Supplement
- S013
- Supplement type
- 135 Review Track For 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
- 2016-08-17
- Decision date
- 2017-02-01
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Approval for updated in-process sampling requirements and to remove redundant inspections.
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