EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003/S015 · decided 2012-09-06
Approval details
- PMA number
- P090003
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2012-08-13
- Decision date
- 2012-09-06
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
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