PMA P920004S001
- Device
- Vasoseal (tm)
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S001
- Decision date
- 1996-08-01
Current openFDA PMA Record
- Device
- VASOSEAL (TM)
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S001
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 1996-08-01
- Decision code
- APPR
- Date received
- 1996-01-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF A REDUCED TIME TO AMBULATION CLAIM TO THE INDICATIOS FOR USE