PMA P100013S029
- Device
- Exoseal Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S029
- Product code
- MGB
- Decision date
- 2025-04-24
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- labeling changes to comply with the current standards, EU Medical Device Regulations and UK Medical Device Regulations
Current openFDA PMA Record#
- Device
- Exoseal Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S029
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2025-04-24
- Decision code
- APPR
- Date received
- 2025-03-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- labeling changes to comply with the current standards, EU Medical Device Regulations and UK Medical Device Regulations