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Absorbable Collagen Hemostatic Agent With Thrombin

Page Type
Product Code
Definition
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Physical State
collagen plus thrombin
Technical Method
Hemostatic agent combining tamponade and acceleration of fibrin clot formation
Target Area
Surgical procedures other than ophthalmic
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
PMA
Device Classification
Class 3
Regulation Number
878.4490
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4490 Absorbable hemostatic agent and dressing

§ 878.4490 Absorbable hemostatic agent and dressing.

(a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.

Absorbable Collagen Hemostatic Agent With Thrombin

Page Type
Product Code
Definition
Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Physical State
collagen plus thrombin
Technical Method
Hemostatic agent combining tamponade and acceleration of fibrin clot formation
Target Area
Surgical procedures other than ophthalmic
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
PMA
Device Classification
Class 3
Regulation Number
878.4490
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4490 Absorbable hemostatic agent and dressing

§ 878.4490 Absorbable hemostatic agent and dressing.

(a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.