PMA P990037S003
- Device
- VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S003
- Decision date
- 2001-03-22
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTINOS FOR USE MANUAL TO INCLUDE THE OUTCOME DATA (REGISTRY RESULTS) REGARDING PATIENTS TREATED WITH PLATELET GP IIB/IIIA INHIBITORS.
Current openFDA PMA Record#
- Device
- VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S003
- Decision date
- 2001-03-22
- Decision code
- APPR
- Date received
- 2001-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTINOS FOR USE MANUAL TO INCLUDE THE OUTCOME DATA (REGISTRY RESULTS) REGARDING PATIENTS TREATED WITH PLATELET GP IIB/IIIA INHIBITORS.