PROPEL AND PROPEL MINI SINUS IMPLANTS
FDA premarket approval P100044/S019 · decided 2015-10-28
Approval details
- PMA number
- P100044
- Supplement
- S019
- 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
- 2015-09-30
- Decision date
- 2015-10-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- ADDING AN INCOMING QUALITY ASSURANCE TEST FOR SHRINKAGE OF THE FIBER COMPONENTS OF THE PROPEL AND PROPEL MINI PRODUCTS AND TO INCREASE THE UPPER LIMIT FOR THE INHERENT VISCOSITY (IV) MANUFACTURING LOT RELEASE SPECIFICATION TO MATCH THE UPPER LIMIT FOR THE CURRENT IV DESIGN SPECIFICATION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |