FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Absorbable Collagen Hemostatic Agent With Thrombin
PMA: P990009
·
Decision Dec 8, 1999
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
- 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
- Approved
- Decision Code
- APPR
- Decision Date
- December 8, 1999
- Date Received
- February 22, 1999
- Expedited Review
- N
- Docket Number
- 00M-1229
Advisory Committee Statement
THE DEVICE IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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 |