PMA P050038S026
- Device
- ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S026
- Product code
- LMG
- Decision date
- 2015-09-09
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- CHANGES IN THE MANUFACTURING PROCESS 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
- S026
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2015-09-09
- Decision code
- OK30
- Date received
- 2015-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN THE MANUFACTURING PROCESS OF THE ARISTA AH FLEXITIP XL-R STAINLESS STEEL COMPONENT.