PMA P100013S026
- Device
- EXOSEAL® Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S026
- Product code
- MGB
- Decision date
- 2022-10-28
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Change to paper weight used with for the EXOSEAL® IFU from 50 lb to 40 lb at Steri-Tek.
Current openFDA PMA Record#
- Device
- EXOSEAL® Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S026
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-10-28
- Decision code
- OK30
- Date received
- 2022-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to paper weight used with for the EXOSEAL® IFU from 50 lb to 40 lb at Steri-Tek.