Skip to content

Actifoam Absorbable Collagen Hemostatic Sponge

by Coletica S.A.

PMA P930030

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 15 Aug 1995

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP930030 Date15 Aug 1995Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Trade Name
Hemostagene(R) Absorbable Coll. Hemostatic Sponge
Generic Name
Agent, absorbable hemostatic, collagen based
PMA Number
FDA Product Code
LMF
Device Class
Class III
Regulation
21 CFR Part 878.4490
Advisory Committee
General, Plastic Surgery
FDA Decision
APWD Approval withdrawn