FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Absorbable Collagen Hemostatic Agent With Thrombin
PMA: P990009
·
Supplement: S076
·
Decision Jun 30, 2025
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Absorbable Collagen Hemostatic Agent With Thrombin
- Trade Name
- FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- PMA Number
- P990009
- Supplement Number
- S076
- Device Class
- FDA Class 3
- Product Code
- PMX
- Generic Name
- Absorbable collagen hemostatic agent with thrombin
- Regulation Number
- 878.4490
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 30, 2025
- Date Received
- June 27, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
qualification of a new ink for use in pad printing on Floseal syringe barrels
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PMX | Absorbable Collagen Hemostatic Agent With Thrombin | FDA class 3 | General, Plastic Surgery |