PMA P150006S004
- Device
- CELT ACD Vascular Closure Device
- Applicant
- Vasorum, Ltd.
- PMA number
- P150006
- Supplement
- S004
- Product code
- MGB
- Decision date
- 2019-08-26
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Expanded e-beam sterilization dose range.
Current openFDA PMA Record#
- Device
- CELT ACD Vascular Closure Device
- Applicant
- Vasorum, Ltd.
- PMA number
- P150006
- Supplement
- S004
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2019-08-26
- Decision code
- OK30
- Date received
- 2019-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expanded e-beam sterilization dose range.