PMA P170012S008
- Device
- HEMOBLAST™ Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S008
- Product code
- PMX
- Decision date
- 2018-08-08
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Change in the in-process specification for the maximum water content of the collagen powder component.
Current openFDA PMA Record#
- Device
- HEMOBLAST™ Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S008
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2018-08-08
- Decision code
- OK30
- Date received
- 2018-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the in-process specification for the maximum water content of the collagen powder component.