PROPEL MINI SINUS IMPLANT, 6011
FDA premarket approval P100044/S003 · decided 2012-11-09
Approval details
- PMA number
- P100044
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROPEL MINI SINUS IMPLANT, 6011
- Generic name
- Drug-eluting sinus stent
- Applicant
- Intersect Ent.
- Date received
- 2012-10-01
- Decision date
- 2012-11-09
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- OWO
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE STENT CRIMPER AND DELIVERY SYSTEMACCESSORY COMPONENTS OF THE DEVICE.
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510(k) clearances by this applicant
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