|
Device | Mometasone Furoate Container Closure System |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S030 |
Date Received | 08/29/2017 |
Decision Date | 09/27/2017 |
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 Addition of automated sealing equipment to add aluminum seals to the mometasone furoate (MF) container closure system utilized to store drug in the manufacturing area. |