PMA P050038S001
- Device
- ARISTA AH ABSORBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S001
- Product code
- LMG
- Decision date
- 2007-06-06
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE UROLOGICAL PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.
Current openFDA PMA Record#
- Device
- ARISTA AH ABSORBABLE HEMOSTAT
- Applicant
- Davol, Inc.
- PMA number
- P050038
- Supplement
- S001
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2007-06-06
- Decision code
- APPR
- Date received
- 2007-05-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE UROLOGICAL PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.