PMA P050038S023
- Device
- ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S023
- Product code
- LMG
- Decision date
- 2015-03-16
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- APPROVAL FOR THE LINE EXTENSION OF THE FLEXITIP XL APPLICATOR FAMILY TO INCLUDE THE FLEXITIP XL-R APPLICATOR. THE MODIFICATION IS BASED UPON THE CURRENT APPLICATOR DESIGN BUT NOW INCLUDES AN ADDITIONAL OUTER STAINLESS STEEL TUBING TO CREATE A RIGID (XL-R) PORTION OF THE APPLICATOR TIP. IN ADDITION, APPROVAL FOR REVISION OF THE INSTRUCTIONS FOR USE OF THE ARISTA AH PRODUCT LABELING IN ORDER TO INFORM USERS OF USE OF THE NEW APPLICATOR DURING ENDOSCOPIC/ LAPAROSCOPIC USES.
Current openFDA PMA Record#
- Device
- ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S023
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2015-03-16
- Decision code
- APPR
- Date received
- 2014-07-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LINE EXTENSION OF THE FLEXITIP XL APPLICATOR FAMILY TO INCLUDE THE FLEXITIP XL-R APPLICATOR. THE MODIFICATION IS BASED UPON THE CURRENT APPLICATOR DESIGN BUT NOW INCLUDES AN ADDITIONAL OUTER STAINLESS STEEL TUBING TO CREATE A RIGID (XL-R) PORTION OF THE APPLICATOR TIP. IN ADDITION, APPROVAL FOR REVISION OF THE INSTRUCTIONS FOR USE OF THE ARISTA AH PRODUCT LABELING IN ORDER TO INFORM USERS OF USE OF THE NEW APPLICATOR DURING ENDOSCOPIC/ LAPAROSCOPIC USES.