PROPEL SINUS, MINI SINUS IMPLANT.
FDA premarket approval P100044/S025 · decided 2016-10-28
Approval details
- PMA number
- P100044
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROPEL SINUS, MINI SINUS IMPLANT.
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2016-09-30
- Decision date
- 2016-10-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Modify the incoming quality assurance test method and associated acceptance criteria for the tensile test for the monofilament fiber component in 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 |