|
Device | PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S026 |
Date Received | 12/27/2016 |
Decision Date | 01/27/2017 |
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 a new semi-automated heating/cooling system and implementation of new curing temperatures and times used to form the applicators of the implant delivery systems. |