PROPEL Contour SInus Implant
FDA premarket approval P100044/S031 · decided 2017-10-13
Approval details
- PMA number
- P100044
- Supplement
- S031
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROPEL Contour SInus Implant
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2017-09-08
- Decision date
- 2017-10-13
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for labeling modifications to clarify instructions for an alternative implant loading method into the delivery system, and for appropriately orienting the delivery system distal tip for the specific sinus being treated.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |