|
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 | S021 |
Date Received | 05/18/2016 |
Decision Date | 06/17/2016 |
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 Modification of two packaging related processes: 1) the addition of an automated Desiccant Dispenser to automatically dispense the desiccants used in the manufacturing product packaging; and 2) the addition of a semi-automated Component Verification System for verifying the presence of components during packaging. These changes are being made to implement the addition of two new equipment systems to facilitate the conversion from manual to automated processes |