PMA P100013S030
- Device
- EXOSEAL® Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S030
- Product code
- MGB
- Decision date
- 2025-05-15
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- removal of redundant Product Final Inspector steps
Current openFDA PMA Record#
- Device
- EXOSEAL® Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S030
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2025-05-15
- Decision code
- OK30
- Date received
- 2025-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of redundant Product Final Inspector steps