PROPEL AND PROPEL MINI SINUS IMPLANT
FDA premarket approval P100044/S022 · decided 2017-07-25
Approval details
- PMA number
- P100044
- Supplement
- S022
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROPEL AND PROPEL MINI SINUS IMPLANT
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2016-06-16
- Decision date
- 2017-07-25
- Days to decision
- 404 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for modification of the in-process drug coating weight specification from ± 5% to ± 7%.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |