PMA P050038S025
- Device
- ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S025
- Product code
- LMG
- Decision date
- 2015-07-31
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- CHANGES IN THE DIMENSIONS OF THE ARISTA AH FLEXITIP XL-R COMPONENT¿S BACK CAVITY BASE INNER DIAMETER, HDPE INCOMING INNER TUBE INNER DIAMETER, AND HDPE TUBE COMPONENT LENGTH.
Current openFDA PMA Record#
- Device
- ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S025
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2015-07-31
- Decision code
- OK30
- Date received
- 2015-07-02
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGES IN THE DIMENSIONS OF THE ARISTA AH FLEXITIP XL-R COMPONENT¿S BACK CAVITY BASE INNER DIAMETER, HDPE INCOMING INNER TUBE INNER DIAMETER, AND HDPE TUBE COMPONENT LENGTH.