PMA P110011S006
- Device
- ASSURANT COBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S006
- Product code
- NIO
- Decision date
- 2014-01-14
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- CHANGE TO YOUR BIOBURDEN TEST METHOD.
Current openFDA PMA Record#
- Device
- ASSURANT COBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S006
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2014-01-14
- Decision code
- OK30
- Date received
- 2013-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO YOUR BIOBURDEN TEST METHOD.