PROPEL AND PROPEL MINI SINUS IMPLANTS
FDA premarket approval P100044/S021 · decided 2016-06-17
Approval details
- PMA number
- P100044
- Supplement
- S021
- 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
- 2016-05-18
- Decision date
- 2016-06-17
- 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 two packaging related processes: 1) the addition of an automated Desiccant Dispenser to automatically dispense the desiccants used in the manufacturing product packaging; and 2) the addition of a semi-automated Component Verification System for verifying the presence of components during packaging. These changes are being made to implement the addition of two new equipment systems to facilitate the conversion from manual to automated processes
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |