PMA P110011S008
- Device
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S008
- Product code
- NIO
- Decision date
- 2015-01-06
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- CHANGE TO THE ROUTINE STERILIZATION DOSE AUDITS.
Current openFDA PMA Record#
- Device
- ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S008
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2015-01-06
- Decision code
- OK30
- Date received
- 2014-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE ROUTINE STERILIZATION DOSE AUDITS.