|
Device | COSEAL SURGICAL SEALANT & ACCESSORIES |
Generic Name | Sealant, polymerizing |
Applicant | BAXTER BIO SCIENCE 32650 N WILSON RD MAIL STOP WG2-3S ROUND LAKE, IL 60073 |
PMA Number | P030039 |
Supplement Number | S015 |
Date Received | 03/02/2010 |
Decision Date | 04/05/2010 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING TO ADDRESS SAFETY-RELATED INFORMATION TO BRING THE LABELING INTO COMPLIANCE WITH THE EUROPEAN MEDICAL DEVICE DIRECTIVE MDD 2007/47/EC. |