PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
FDA premarket approval P100044/S010 · decided 2013-08-13
Approval details
- PMA number
- P100044
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2013-06-25
- Decision date
- 2013-08-13
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) AND LABELS THAT ENHANCE THE SAFETY IN THE USE OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |