PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT
FDA premarket approval P100044/S016 · decided 2014-05-23
Approval details
- PMA number
- P100044
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2014-04-23
- Decision date
- 2014-05-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- ADDITION OF A NEW POUCH SEALING EQUIPMENT, SENCORP WHITE HEAT SEALER WITH VACCUUM AND GAS PURGE MODEL 12-PV/2, TO THE EXISTING MANUFACTURING LINE FOR THE PACKAGING 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 |