PMA P110040S005
- Device
- COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA
- Applicant
- Medtronic Vascular
- PMA number
- P110040
- Supplement
- S005
- Product code
- NIP
- Decision date
- 2014-04-03
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS.
Current openFDA PMA Record#
- Device
- COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA
- Applicant
- Medtronic Vascular
- PMA number
- P110040
- Supplement
- S005
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2014-04-03
- Decision code
- OK30
- Date received
- 2014-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS.