Supera Peripheral Stent System
FDA premarket approval P120020/S017 · decided 2018-01-25
Approval details
- PMA number
- P120020
- Supplement
- S017
- Supplement type
- 135 Review Track For 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
- 2017-09-28
- Decision date
- 2018-01-25
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval to change the ethylene oxide (EO) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.
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