PROPEL
FDA premarket approval P100044/S020 · decided 2016-08-24
Approval details
- PMA number
- P100044
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROPEL
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2016-03-25
- Decision date
- 2016-08-24
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for a manufacturing site located at Synergy Health AST, LLC, Lakevillle Hwy, Suite 120, Petaluma, CA 94954 as a backup sterilization facility for the Propel and Propel Mini Sinus Implants.
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510(k) clearances by this applicant
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| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |