PMA P100013S018
- Device
- EXOSEAL Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S018
- Product code
- MGB
- Decision date
- 2019-03-26
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Relocate the manufacturing facility for the bioabsorbable component.
Current openFDA PMA Record#
- Device
- EXOSEAL Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S018
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-03-26
- Decision code
- OK30
- Date received
- 2019-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocate the manufacturing facility for the bioabsorbable component.