PMA P110011S010
- Device
- ASSURANT COLBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S010
- Product code
- NIO
- Decision date
- 2015-07-09
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
Current openFDA PMA Record#
- Device
- ASSURANT COLBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P110011
- Supplement
- S010
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2015-07-09
- Decision code
- APPR
- Date received
- 2015-03-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.