PMA P100013S010
- Device
- EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S010
- Product code
- MGB
- Decision date
- 2014-04-23
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- BRING MANUFACTURING OF AN INJECTION MOLDED COMPONENT IN-HOUSE AND REPLACE THE SINGLE- WITH THE MULTI-CAVITY MOLDING PROCESS.
Current openFDA PMA Record#
- Device
- EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S010
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2014-04-23
- Decision code
- OK30
- Date received
- 2014-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- BRING MANUFACTURING OF AN INJECTION MOLDED COMPONENT IN-HOUSE AND REPLACE THE SINGLE- WITH THE MULTI-CAVITY MOLDING PROCESS.