Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S035 |
Date Received | 08/24/2018 |
Decision Date | 09/21/2018 |
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 Extending the shelf life of the drug coating solution used in the manufacture of the Propel family of sinus implants, and to scale up the solution storage volume. |
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