PMA P920004S009
- Device
- VASOSEAL ANCHOR DEVICE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S009
- Product code
- MGB
- Decision date
- 1998-06-12
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for modifying the precautions section of the VasoSeal(R) Instructions for Use regarding repuncture of a previously treated VasoSeal(R) site.
Current openFDA PMA Record
- Device
- VASOSEAL ANCHOR DEVICE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P920004
- Supplement
- S009
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 1998-06-12
- Decision code
- APPR
- Date received
- 1997-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifying the precautions section of the VasoSeal(R) Instructions for Use regarding repuncture of a previously treated VasoSeal(R) site.