Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants
FDA premarket approval P100044/S044 · decided 2019-10-08
Approval details
- PMA number
- P100044
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2019-09-10
- Decision date
- 2019-10-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- New packaging vision inspection system.
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510(k) clearances by this applicant
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