Device, Hemostasis, Vascular
Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
- PMA Number
- P990037
- Supplement Number
- S024
- Device Class
- FDA Class 3
- Product Code
- MGB
- Generic Name
- Device, hemostasis, vascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 22, 2006
- Date Received
- June 22, 2006
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 07M-0188
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | FDA class 3 | Unknown |