Misago RX Self-expanding Peripheral Stent
FDA premarket approval P140002/S011 · decided 2018-08-01
Approval details
- PMA number
- P140002
- Supplement
- S011
- 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
- 2018-04-02
- Decision date
- 2018-08-01
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- Statement
- Approval for a change to the supplier of the device pouch.
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510(k) clearances by this applicant
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|---|---|---|
| R2P Navicross (K231044) | Terumo Medical Corporation | 2023-07-27 |
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| Glidesheath Slender (K173831) | Terumo Medical Corporation | 2018-05-08 |
| Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995) | Terumo Medical Corporation | 2017-11-21 |
| R2P Destination Slender Guiding Sheath (K171491) | Terumo Medical Corporation | 2017-10-05 |
| Glidesheath (K152173) | Terumo Medical Corporation | 2015-12-01 |