PMA P920004S004
- Device
- VASOSEAL (TM)
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S004
- Product code
- MGB
- Decision date
- 1996-12-02
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- CHANGES TO THE INDICATIONS FOR USE TO INCLUDE USE OF VASOSEAL(R) FOLLOWING NON-CORONARY ANGIOGRAPHY AND NON-CORONARY BALLOON ANGIOPLASTY PROCEDURES
Current openFDA PMA Record
- Device
- VASOSEAL (TM)
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S004
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 1996-12-02
- Decision code
- APPR
- Date received
- 1996-10-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- CHANGES TO THE INDICATIONS FOR USE TO INCLUDE USE OF VASOSEAL(R) FOLLOWING NON-CORONARY ANGIOGRAPHY AND NON-CORONARY BALLOON ANGIOPLASTY PROCEDURES