INTERSECTENT PROPEL MINI SINUS IMPLANT
FDA premarket approval P100044/S008 · decided 2013-07-17
Approval details
- PMA number
- P100044
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Trade name
- INTERSECTENT PROPEL MINI SINUS IMPLANT
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2013-03-04
- Decision date
- 2013-07-17
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- AGREED TO THE RECOMMENDATION TO REVISE THE STABILITY PROTOCOL TO REFLECT THE DRUG RELEASE ACCEPTANCE CRITERIA OF ± 12% OF THE TARGET VALUE USED FOR PRODUCT RELEASE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |