PMA P110040S002
- Device
- COMPLETE SE SFA/PPA VASCULAR STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110040
- Supplement
- S002
- Product code
- NIP
- Decision date
- 2014-01-14
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- CHANGE TO YOUR BIOBURDEN TEST METHOD.
Current openFDA PMA Record#
- Device
- COMPLETE SE SFA/PPA VASCULAR STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110040
- Supplement
- S002
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- 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.