Premarket Approval (PMA)

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: VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
• Generic Name: Device, hemostasis, vascular
• Applicant: Vascular Solutions, Inc.; 6464 SYCAMORE COURT NORTH; MINNEAPOLIS, MN 55369
• PMA Number: P990037
• Supplement Number: S024
• Date Received: 06/22/2006
• Decision Date: 12/22/2006
• Product Code: MGB
• Docket Number: 07M-0188
• Notice Date: 05/11/2007
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR A NEW INDICATION FOR USE FOR THE D-STAT FLOWABLE HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN HIGH-RISK ANTI-COAGULATED PATIENTS UNDERGOING IMPLANTATION OF A PULSE GENERATOR (E.G., PACEMAKER OR ICD) TO REDUCE THE FREQUENCY OF CLINICALLY RELEVANT HEMATOMA FORMATION IN THE PREPECTORAL POCKET. D-STAT FLOWABLE IS INDICATED FOR USE IN HIGH-RISK ANTI-COAGULATED PATIENTS UNDERGOING IMPLANTATION OF A PULSE GENERATOR (E.G., PACEMAKER OR ICD TO REDUCE THE FREQUENCY OF CLINICALLY RELEVANT HEMATOMA FORMATION IN THE PREPECTORAL POCKET. HIGH-RISK PATIENTS ARE DEFINED AS THOSE WHOSE ANTI-COAGULATION REGIMENS WILL RESUME WITHIN 24 HOURS OF IMPLANT. CLINICALLY RELEVANT HEMATOMAS ARE DEFINED AS THOSE THAT RESULT IN AN ALTERATION IN THE STANDARD OF CARE RESULTANT OF HEMATOMA FORMATION INCLUDING ALTERATION (I.E. SUSPENSION OR DISCONTINUATION) OF THE ANTICOAGULANT THERAPY REGIMEN (HEPARIN, LMWH, WARFARIN, OR CLOPIDOGREL), APPLICATION OF A COMPRESSION BANDAGE AND EVACUATION OF THE HEMATOMA.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling