Propel Family of Sinus Implants
FDA premarket approval P100044/S045 · decided 2020-04-24
Approval details
- PMA number
- P100044
- Supplement
- S045
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Propel Family of Sinus Implants
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2020-03-26
- Decision date
- 2020-04-24
- Days to decision
- 29 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 Instructions for Use (IFU) to enhance the safe use of the Propel Family of Implants (Propel, Propel Mini and Propel Contour).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |