Supera Peripheral Stent System
FDA premarket approval P120020/S016 · decided 2017-07-14
Approval details
- PMA number
- P120020
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Supera Peripheral Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- Date received
- 2017-06-14
- Decision date
- 2017-07-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Change the dilution used for routine lot release pyrogenic testing for the Supera Peripheral Stent System from 1:5 to 1:100.
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