|
Device | Propel Contour Sinus Implant |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S040 |
Date Received | 05/01/2019 |
Decision Date | 05/31/2019 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |