MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA premarket approval P140002/S002 · decided 2017-03-08
Approval details
- PMA number
- P140002
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Terumo Medical Corporation
- Date received
- 2016-05-06
- Decision date
- 2017-03-08
- Days to decision
- 306 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- Statement
- Approval for changes to the device delivery system, associated labeling changes, new manufacturing equipment and new material suppliers.
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