PMA P050043
- Device
- Femoral Introducer Sheath and Hemostasis(FISH) Device
- Applicant
- Morris Innovative Research, Inc.
- PMA number
- P050043
- Supplement
- S008
- Product code
- MGB
- Decision date
- 2018-09-19
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Replacement of the current laser cutting equipment with a new laser cutting equipment for the SIS patch cutting operation.
Current openFDA PMA Record#
- Device
- Femoral Introducer Sheath and Hemostasis(FISH) Device
- Applicant
- Morris Innovative Research, Inc.
- PMA number
- P050043
- Supplement
- S008
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-09-19
- Decision code
- OK30
- Date received
- 2018-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the current laser cutting equipment with a new laser cutting equipment for the SIS patch cutting operation.