PMA P120020S030
- Device
- Supera Peripheral Stent System
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- PMA number
- P120020
- Supplement
- S030
- Product code
- NIP
- Decision date
- 2023-01-31
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for a change in supplier's adhesive formulation and manufacturing.
Current openFDA PMA Record#
- Device
- Supera Peripheral Stent System
- Applicant
- Abbott Vascular (Idef Technologies Inc)
- PMA number
- P120020
- Supplement
- S030
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2023-01-31
- Decision code
- APPR
- Date received
- 2022-11-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in supplier's adhesive formulation and manufacturing.