Misago RX Self-expanding Peripheral Stent
FDA premarket approval P140002/S014 · decided 2018-10-01
Approval details
- PMA number
- P140002
- Supplement
- S014
- 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
- 2018-04-19
- Decision date
- 2018-10-01
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- Statement
- Approval for changes to release testing sampling and elimination of release testing for certain attributes.
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