|
Device | Intersect ENT Propel Contour Sinus Implant Component Verification System Generation II |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S028 |
Date Received | 04/27/2017 |
Decision Date | 05/24/2017 |
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 packaging inspection system for the Propel Contour Sinus Implant. |