PMA P100044S043
- Device
- Propel
- Applicant
- Intersect Ent.
- Product code
- OWO
- Decision date
- 2020-02-28
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for a manufacturing site located at Steri-Tek, Smart World LLC, dba Steri-Tek, 48225 Lakeview Blvd., Fremont, CA 94538, which performs sterilization.
Current openFDA PMA Record#
- Device
- Propel
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S043
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2020-02-28
- Decision code
- APPR
- Date received
- 2019-09-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Steri-Tek, Smart World LLC, dba Steri-Tek, 48225 Lakeview Blvd., Fremont, CA 94538, which performs sterilization.