Propel Contour Sinus Implant
FDA premarket approval P100044/S033 · decided 2018-06-28
Approval details
- PMA number
- P100044
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Propel Contour Sinus Implant
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2018-06-08
- Decision date
- 2018-06-28
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Modify the handle tensile strength specification for the delivery system for the Propel Contour Sinus Implant.
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