|
Device | INTERSECTENT 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 | S008 |
Date Received | 03/04/2013 |
Decision Date | 07/17/2013 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement AGREED TO THE RECOMMENDATION TO REVISE THE STABILITY PROTOCOL TO REFLECT THE DRUG RELEASE ACCEPTANCE CRITERIA OF ± 12% OF THE TARGET VALUE USED FOR PRODUCT RELEASE. |