PMA P920004
- Device
- VASOSEAL
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S012
- Product code
- MGB
- Decision date
- 2008-01-11
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- CHANGE TO THE SPONGE PLUG RINSE SYSTEM FROM A SEMI-AUTOMATED TO A FULLY AUTOMATED SYSTEM.
Current openFDA PMA Record
- Device
- VASOSEAL
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S021
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2008-01-11
- Decision code
- OK30
- Date received
- 2007-12-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SPONGE PLUG RINSE SYSTEM FROM A SEMI-AUTOMATED TO A FULLY AUTOMATED SYSTEM.