PMA P100013S034
- Device
- Exoseal Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S034
- Product code
- MGB
- Decision date
- 2026-06-23
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- instructions for use labeling changes
Current openFDA PMA Record#
- Device
- Exoseal Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S034
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-06-23
- Decision code
- APPR
- Date received
- 2026-05-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- instructions for use labeling changes