- Device
- HEMOBLAST™ Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S027
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2021-10-13
- Decision code
- OK30
- Date received
- 2021-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the location of performing Differential Scanning Calorimetry testing on the finished HEMOBLAST Bellows hemostatic powder to Biom'Up's manufacturing facility in St-Priest, France.