Cordis PRECISE Nitinol Stent System
FDA premarket approval P030047/S038 · decided 2019-04-30
Approval details
- PMA number
- P030047
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cordis PRECISE Nitinol Stent System
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2019-04-01
- Decision date
- 2019-04-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Process improvement to upgrade the sterilization vessel control system and associated mechanical components.
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