|
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 | S017 |
Date Received | 04/02/2015 |
Decision Date | 05/07/2015 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST IN DENVER, COLORADO. |