PROPEL AND PROPEL MINI SINUS IMPLANTS
FDA premarket approval P100044/S014 · decided 2013-12-06
Approval details
- PMA number
- P100044
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROPEL AND PROPEL MINI SINUS IMPLANTS
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2013-11-12
- Decision date
- 2013-12-06
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- ADD AN ALTERNATE MATERIAL SUPPLIER.
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 |