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PMA P100044S038

Device
Propel Mini Sinus Implant
Applicant
Intersect Ent.
Product code
OWO
Decision date
2019-07-24
Generic name
Drug-eluting sinus stent
Approval order statement
Approval for the introduction of a delivery system with a straight applicator for ethmoid sinus access and serves as an alternative to the approved delivery system with a curved applicator.

Current openFDA PMA Record#

Device
Propel Mini Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S038
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2019-07-24
Decision code
APPR
Date received
2019-04-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the introduction of a delivery system with a straight applicator for ethmoid sinus access and serves as an alternative to the approved delivery system with a curved applicator.