Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 | S049 |
Date Received | 03/28/2022 |
Decision Date | 06/24/2022 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the change of e-beam sterilization dose for the Propel Contour Sinus Implant. |
|
|