PMA P050011S008
- Device
- ADEPT Adhesion Reduction Solution
- Applicant
- Baxter Healthcare Corp
- PMA number
- P050011
- Supplement
- S008
- Product code
- MCN
- Decision date
- 2020-08-21
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- Approval for bag fill volume changes to the polyvinylchloride storage bag for the ADEPT® Adhesion Reduction Solution.
Current openFDA PMA Record#
- Device
- ADEPT Adhesion Reduction Solution
- Applicant
- Baxter Healthcare Corp
- PMA number
- P050011
- Supplement
- S008
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2020-08-21
- Decision code
- APPR
- Date received
- 2020-04-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for bag fill volume changes to the polyvinylchloride storage bag for the ADEPT® Adhesion Reduction Solution.