PMA P100013S015
- Device
- Cordis Exoseal Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S015
- Product code
- MGB
- Decision date
- 2017-12-14
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to add Steri-Tek as a new E-beam sterilization site for the Exoseal Vascular Closure Device.
Current openFDA PMA Record#
- Device
- Cordis Exoseal Vascular Closure Device
- Applicant
- Cordis US Corporation
- PMA number
- P100013
- Supplement
- S015
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2017-12-14
- Decision code
- APPR
- Date received
- 2017-08-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add Steri-Tek as a new E-beam sterilization site for the Exoseal Vascular Closure Device.