BARD E-LUMINEXX VASCULAR STENT
FDA premarket approval P080007/S005 · decided 2011-09-02
Approval details
- PMA number
- P080007
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BARD E-LUMINEXX VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2011-03-11
- Decision date
- 2011-09-02
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR TWO CHANGES TO THE VALIDATED ETO STERILIZATION CYCLE (#14) CHAMBER PRESSURE PARAMETERS, FOR THE DEVICE.
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