|
Device | FLOSEAL ENDOSCOPIC APPLICATOR |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Supplement Number | S027 |
Date Received | 10/15/2009 |
Decision Date | 02/02/2010 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING CHANGE TO REMOVE THE ETCHED TERM FLOSEAL FROM THE CANNULA AND SOME LABELING AND INSTRUCTIONS CLARIFICATIONS. |