PMA P110011S009
- Device
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S009
- Product code
- NIO
- Decision date
- 2015-09-09
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR A CHANGE TO IN-PROCESS TESTING PROCEDURES.
Current openFDA PMA Record#
- Device
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S009
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2015-09-09
- Decision code
- APPR
- Date received
- 2015-02-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO IN-PROCESS TESTING PROCEDURES.