|
Device | Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S050 |
Date Received | 10/05/2022 |
Decision Date | 11/04/2022 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for an additional control to ensure the spray coaters are running optimally during the manufacturing process. |