AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set
FDA premarket approval P980037/S066 · decided 2017-10-16
Approval details
- PMA number
- P980037
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2017-07-18
- Decision date
- 2017-10-16
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for design and processing changes to the outlet adapter assembly for the Angiojet Thrombectomy Sets.
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