Propel, Propel mini and Propel Contour Sinus Implants
FDA premarket approval P100044/S032 · decided 2018-06-01
Approval details
- PMA number
- P100044
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel, Propel mini and Propel Contour Sinus Implants
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2018-05-02
- Decision date
- 2018-06-01
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Modification of the pneumatic crimper used in the manufacturing of the delivery systems for the Propel, Propel mini and Propel Contour Sinus Implants.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |