PMA P920004S005
- Device
- VASOSEAL (TM)
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S005
- Product code
- MGB
- Decision date
- 1997-01-07
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL FOR INCLUDING THE VASOSEAL(R) PATIENT INFORMATION GUIDE IN THE SHIPPING CONTAINER FOR THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE.
Current openFDA PMA Record
- Device
- VASOSEAL (TM)
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S005
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 1997-01-07
- Decision code
- APPR
- Date received
- 1996-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR INCLUDING THE VASOSEAL(R) PATIENT INFORMATION GUIDE IN THE SHIPPING CONTAINER FOR THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE.