PMA P140002S002
- Device
- MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S002
- Product code
- NIP
- Decision date
- 2017-03-08
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for changes to the device delivery system, associated labeling changes, new manufacturing equipment and new material suppliers.
Current openFDA PMA Record#
- Device
- MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S002
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2017-03-08
- Decision code
- APPR
- Date received
- 2016-05-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the device delivery system, associated labeling changes, new manufacturing equipment and new material suppliers.