COMPLETE SE VASCULAR STENT SYSTEM
FDA premarket approval P090006/S007 · decided 2011-09-07
Approval details
- PMA number
- P090006
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular
- Date received
- 2011-08-08
- Decision date
- 2011-09-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- REDUCTION IN PYROGEN TESTING SAMPLE SIZE.
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