PMA P110011S013
- Device
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S013
- Product code
- NIO
- Decision date
- 2017-02-01
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Approval for updated in-process sampling requirements and to remove redundant inspections.
Current openFDA PMA Record#
- Device
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S013
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2017-02-01
- Decision code
- APPR
- Date received
- 2016-08-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updated in-process sampling requirements and to remove redundant inspections.