FDA.reportPublic FDA data

PMA P100044S040

Device
Propel Contour Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S040
Product code
OWO
Decision date
2019-05-31
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
Change to the in-process acceptance criterion for the mometasone furoate (MF) coating solution assay from a concentration range of 5.9- 6.2 mg/mL to 5.8- 6.1 mg/mL to align with the manufacturing target and lot history data.

Current openFDA PMA Record#

Device
Propel Contour Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S040
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2019-05-31
Decision code
OK30
Date received
2019-05-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the in-process acceptance criterion for the mometasone furoate (MF) coating solution assay from a concentration range of 5.9- 6.2 mg/mL to 5.8- 6.1 mg/mL to align with the manufacturing target and lot history data.