PMA P100013S021
- Device
- CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S021
- Product code
- MGB
- Decision date
- 2021-09-28
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Change to the degreasing solution and system used in the manufacturing of the indicator wire component of the EXOSEAL Vascular Closure Device.
Current openFDA PMA Record#
- Device
- CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S021
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-09-28
- Decision code
- OK30
- Date received
- 2021-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the degreasing solution and system used in the manufacturing of the indicator wire component of the EXOSEAL Vascular Closure Device.