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. |
|
Device | Preveleak Surgical Sealant |
Generic Name | Sealant, polymerizing |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P100030 |
Supplement Number | S017 |
Date Received | 03/31/2023 |
Decision Date | 04/28/2023 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Alternative bacterial endotoxin testing methods for the Preveleak Surgical Sealant. |
|
|