|
Device | Propel and Propel Mini Sinus Implants |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S034 |
Date Received | 08/08/2018 |
Decision Date | 09/07/2018 |
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 Changes to the qualification protocol for the fiber used in the manufacture of the Propel and Propel Mini Sinus Implants. |