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PMA P100044S037

Device
Propel Contour Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S037
Product code
OWO
Decision date
2019-02-28
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
Approval for modifications to the design and manufacturing of the delivery system, including the implementation of mechanical press fit bond joints, new dimensional specifications, revisions to the tip molding process, and a redefined tensile strength specification for the applicator.

Current openFDA PMA Record#

Device
Propel Contour Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S037
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2019-02-28
Decision code
APPR
Date received
2018-11-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modifications to the design and manufacturing of the delivery system, including the implementation of mechanical press fit bond joints, new dimensional specifications, revisions to the tip molding process, and a redefined tensile strength specification for the applicator.