Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
FDA premarket approval P100044/S050 · decided 2022-11-04
Approval details
- PMA number
- P100044
- Supplement
- S050
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2022-10-05
- Decision date
- 2022-11-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for an additional control to ensure the spray coaters are running optimally during the manufacturing process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |