PMA P230038
- Device
- AbsorbaSeal 5.6.7F Vascular Closure Device
- Applicant
- Cyndrx, LLC
- PMA number
- P230038
- Product code
- MGB
- Decision date
- 2026-06-05
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- the AbsorbaSeal 5.6.7F Vascular Closure Device. This device is indicated for use in percutaneous closure of femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures utilizing 5, 6, or 7F procedural sheaths.
Current openFDA PMA Record#
- Device
- AbsorbaSeal 5.6.7F Vascular Closure Device
- Applicant
- Cyndrx, LLC
- PMA number
- P230038
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-06-05
- Decision code
- APPR
- Date received
- 2023-11-17
- Approval order statement
- the AbsorbaSeal 5.6.7F Vascular Closure Device. This device is indicated for use in percutaneous closure of femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures utilizing 5, 6, or 7F procedural sheaths.