EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003/S020 · decided 2012-12-21
Approval details
- PMA number
- P090003
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2012-11-27
- Decision date
- 2012-12-21
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
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