Propel
FDA premarket approval P100044/S043 · decided 2020-02-28
Approval details
- PMA number
- P100044
- Supplement
- S043
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2019-09-03
- Decision date
- 2020-02-28
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |