Propel Contour Sinus Implant
FDA premarket approval P100044/S037 · decided 2019-02-28
Approval details
- PMA number
- P100044
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Propel Contour Sinus Implant
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2018-11-30
- Decision date
- 2019-02-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for modifications to the design and manufacturing of the delivery system, including the implementation of mechanical press fit bond joints, new dimensional specifications, revisions to the tip molding process, and a redefined tensile strength specification for the applicator.
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 |