MISAGO RX SELF-EXPANDING PERIPHERAL STENT
FDA premarket approval P140002/S001 · decided 2015-06-24
Approval details
- PMA number
- P140002
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MISAGO RX SELF-EXPANDING PERIPHERAL STENT
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Terumo Medical Corporation
- Date received
- 2015-05-26
- Decision date
- 2015-06-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- Statement
- MODIFICATIONS TO THE DELIVERY SYSTEM, CHANGE TO TWO OF THE SUBCOMPONENTS OF THE DELIVERY CATHETER COMPONENT.
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