Misago RX Self-expanding Peripheral Stent
FDA premarket approval P140002/S006 · decided 2017-01-05
Approval details
- PMA number
- P140002
- Supplement
- S006
- Supplement type
- 135 Review Track For 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
- 2016-09-21
- Decision date
- 2017-01-05
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- Statement
- Approval for an additional supplier for silicone oil used to lubricate the stent release mechanism of the delivery catheter.
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