PMA P120020S035
- Device
- Supera Peripheral Stent System
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- PMA number
- P120020
- Supplement
- S035
- Product code
- NIP
- Decision date
- 2026-02-05
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- approval for a change to the outer sheath coating solution process
Current openFDA PMA Record#
- Device
- Supera Peripheral Stent System
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- PMA number
- P120020
- Supplement
- S035
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-02-05
- Decision code
- OK30
- Date received
- 2026-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change to the outer sheath coating solution process