EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003/S035 · decided 2014-10-10
Approval details
- PMA number
- P090003
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-07-22
- Decision date
- 2014-10-10
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MRI SECTIONS OF THE PRODUCT LABELING.
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