Propel®, Propel® Mini, Propel® Contour Sinus Implants
FDA premarket approval P100044/S056 · decided 2025-02-12
Approval details
- PMA number
- P100044
- Supplement
- S056
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel®, Propel® Mini, Propel® Contour Sinus Implants
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2025-01-16
- Decision date
- 2025-02-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- adding Medtronic North Haven Laboratory Services (Medtronic-North Haven) as an alternate test facility for in-process bioburden monitoring and periodic sterility testing of the Propel Product Family (Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant, and Propel Mini Sinus Implant with Straight Delivery System)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |