PMA P100013S013
- Device
- CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S013
- Product code
- MGB
- Decision date
- 2016-06-30
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Transfer the indicator wire component's manufacturing process to an alternate manufacturing site.
Current openFDA PMA Record#
- Device
- CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S013
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-06-30
- Decision code
- OK30
- Date received
- 2016-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer the indicator wire component's manufacturing process to an alternate manufacturing site.