| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | HEMOBLAST™ Bellows |
|---|
| Generic Name | Absorbable collagen hemostatic agent with thrombin |
|---|
| Regulation Number | 878.4490 |
|---|
| Applicant | Dilon Technologies, Inc.
12050 Jefferson Ave., Suite 340
Newport News, VA 23606 |
|---|
| PMA Number | P170012 |
|---|
| Date Received | 03/30/2017 |
|---|
| Decision Date | 12/15/2017 |
|---|
| Product Code |
PMX |
| Docket Number | 17M-6896 |
|---|
| Notice Date | 12/18/2017 |
|---|
| Advisory Committee |
General & Plastic Surgery |
|---|
| Clinical Trials | NCT02502019
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | Yes |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
Approval of the Hemoblast Bellows. This device is indicated for surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S020 S006 S007 S008 S009 S001 S002 S014 S015 S018 S023
S012 S024 S027 S026 S030 S031 S029 S005 S004 S003 S010 S011
S016 S019 S021 S022 S017 S013 S025 S028 |
|
|
