Express LD Iliac Premounted Stent System
FDA premarket approval P090003/S051 · decided 2021-04-30
Approval details
- PMA number
- P090003
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Express LD Iliac Premounted Stent System
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-03-01
- Decision date
- 2021-04-30
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the use of an alternate strain relief component of the delivery system Y-connector assembly.
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