EXPRESS LD ILIAC PREMOUNTED SYSTEM
FDA premarket approval P090003/S037 · decided 2015-08-12
Approval details
- PMA number
- P090003
- Supplement
- S037
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS LD ILIAC PREMOUNTED SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-11-14
- Decision date
- 2015-08-12
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.
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