INTERSECT ENT PROPEL MINI SINUS IMPLANT
FDA premarket approval P100044/S012 · decided 2014-01-31
Approval details
- PMA number
- P100044
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSECT ENT PROPEL MINI SINUS IMPLANT
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2013-09-30
- Decision date
- 2014-01-31
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- APPROVAL TO REVISE THE RELEASE RATE SPECIFICATION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |