Propel Family of Sinus Implants
FDA premarket approval P100044/S036 · decided 2019-01-10
Approval details
- PMA number
- P100044
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Propel Family of Sinus Implants
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2018-10-12
- Decision date
- 2019-01-10
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for extending the storage shelf life of the component fibers used in the manufacture of the Propel Family of Sinus Implants (Propel, Propel Mini, Propel Contour) to 20 months.
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