PMA P990037S006
- Device
- VASCULAR SOLUTIONS DUETT SEALING DEVICE
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S006
- Decision date
- 2001-06-14
- Approval order statement
- APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN THE PRECAUTIONS AND INSTRUCTIONS.
Current openFDA PMA Record#
- Device
- VASCULAR SOLUTIONS DUETT SEALING DEVICE
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S006
- Decision date
- 2001-06-14
- Decision code
- APPR
- Date received
- 2001-05-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN THE PRECAUTIONS AND INSTRUCTIONS.