EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM
FDA premarket approval P090003/S038 · decided 2015-03-06
Approval details
- PMA number
- P090003
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2015-02-05
- Decision date
- 2015-03-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- MODIFY THE TOOLPATH AND SOFTWARE ASSOCIATED WITH THE STENT CUTTING LASERS.
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