PMA P990037S024
- Device
- VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S024
- Product code
- MGB
- Decision date
- 2006-12-22
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990037S024B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S024
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2006-12-22
- Decision code
- APPR
- Date received
- 2006-06-22
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.