PMA P100013S019
- Device
- Cordis EXOSEAL Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S019
- Product code
- MGB
- Decision date
- 2019-05-01
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Change in 2nd tier supplier for the Brite Finish Indicator Wire Lumen Tube component.
Current openFDA PMA Record#
- Device
- Cordis EXOSEAL Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S019
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-05-01
- Decision code
- OK30
- Date received
- 2019-04-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in 2nd tier supplier for the Brite Finish Indicator Wire Lumen Tube component.