PMA P050038S019
- Device
- ARISTA AH ABSORRBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S019
- Product code
- LMG
- Decision date
- 2014-02-27
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- APPROVAL FOR A LARGER (18 GRAM) BELLOW CONTAINER FOR THE 5 GRAM ARISTA AH DEVICE AND INCREASES IN THE DIMENSIONS OF THE DEVICE PACKAGING, SPECIFICALLY, THE FOIL AND TYVEK POUCHES AND SHELF AND SHIPPER BOXES.
Current openFDA PMA Record#
- Device
- ARISTA AH ABSORRBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S019
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2014-02-27
- Decision code
- APPR
- Date received
- 2013-12-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A LARGER (18 GRAM) BELLOW CONTAINER FOR THE 5 GRAM ARISTA AH DEVICE AND INCREASES IN THE DIMENSIONS OF THE DEVICE PACKAGING, SPECIFICALLY, THE FOIL AND TYVEK POUCHES AND SHELF AND SHIPPER BOXES.