COMPLETE SE VASCULAR STENT SYSTEM - ILLIAC
FDA premarket approval P090006/S017 · decided 2016-06-01
Approval details
- PMA number
- P090006
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM - ILLIAC
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular
- Date received
- 2016-05-05
- Decision date
- 2016-06-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Changes to the stent manufacturing process.
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