Propel® Contour Sinus Implant
FDA premarket approval P100044/S055 · decided 2024-11-25
Approval details
- PMA number
- P100044
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel® Contour Sinus Implant
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2024-10-28
- Decision date
- 2024-11-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- replacement of the lot release residual solvent analytical testing requirement with annual testing
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |