Innova Self-Expanding Stent System
FDA premarket approval P140028/S025 · decided 2017-05-26
Approval details
- PMA number
- P140028
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Innova Self-Expanding Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Boston Scientific Corporation
- Date received
- 2017-04-28
- Decision date
- 2017-05-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Updates to the Programmable Logic Controller (PLC) software used for sterilization Chamber 3, an update to the vacuum pump system used in Chamber 3, and an update to the validation documentation structure used to support the system.
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