SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S009 · decided 2007-11-30
Approval details
- PMA number
- P020036
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Trade name
- SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2007-11-02
- Decision date
- 2007-11-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
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