Propel and Propel Mini Sinus Implants
FDA premarket approval P100044/S048 · decided 2021-04-09
Approval details
- PMA number
- P100044
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Propel and Propel Mini Sinus Implants
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2021-01-11
- Decision date
- 2021-04-09
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for the change of e-beam sterilization dose for the Propel and Propel Mini Sinus Implants.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |