PMA P050038S028
- Device
- ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S028
- Product code
- LMG
- Decision date
- 2016-01-07
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- REQUESTED CHANGES IN THE SUPPLIER OF THE ARISTA AH FLEXITIP XL-R STAINLESS STEEL COMPONENT.
Current openFDA PMA Record#
- Device
- ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S028
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2016-01-07
- Decision code
- OK30
- Date received
- 2015-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REQUESTED CHANGES IN THE SUPPLIER OF THE ARISTA AH FLEXITIP XL-R STAINLESS STEEL COMPONENT.