|
Device | GELFOAM (ABSORBABLE GELATIN) POWDER,USP |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | PFIZER, INC. 235 EAST 42ND ST. NEW YORK, NY 10017 |
PMA Number | N18286 |
Supplement Number | S025 |
Date Received | 04/17/2013 |
Decision Date | 06/03/2013 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR LABEL CHANGES TO THE INSTRUCTIONS FOR USE: FOR THE FOLLOWING DEVICE ITERATIONS:1) GELFOAM PLUS -ORIGINAL SPONGE IFU- NEEDLELESS;2) GELFOAM PLUS- POWDER IFU-NEEDLELESS; 3) GELFOAM PLUS - COMPRESSED SPONGE IFU NEEDLELESS;4) GELFOAM ABSORBABLE GELATIN) SPONGE; 5) GELFOAM (ABSORBABLE GELATIN) DENTAL SPONGE; 6) GELFOAM (ABSORBABLE GELATIN) COMPRESSED SPONGE; AND 7) GELFOAM (ABSORBABLE GELATIN) POWDER.ADD THE PRECAUTIONARY STATEMENT:POSITIONING OF THE PATIENT RESULTING IN NEGATIVE PERIPHERAL VENOUS PRESSURE DURING A PROCEDURE HAS BEEN REPORTED TO BE A CONTRIBUTING FACTOR RESULTING IN LIFE-THREATENING THROMBOEMBOLIC EVENTS.2. FOR THE FOLLOWING DEVICE ITERATIONS:1) GELFOAM (ABSORBABLE GELATIN) SPONGE; 2) GELFOAM (ABSORBABLE GELATIN) DENTAL SPONGE; 3) GELFOAM (ABSORBABLE GELATIN) COMPRESSED SPONGE; AND 4) GELFOAM (ABSORBABLE GELATIN) POWDER.MAKE MINOR CHANGES TO THE EXISTING PRECAUTIONARY STATEMENT: ALTHOUGH THE SAFETY AND EFFICACY OF THE COMBINED USE OF GELFOAM WITH OTHER AGENTS SUCH AS TOPICAL THROMBIN HAS NOT BEEN EVALUATED IN PHARMACIA- CONTROLLED CLINICAL TRIALS, IF IN THE PHYSICIANS JUDGMENT CONCURRENT USE OF TOPICAL THROMBIN OTHER AGENTS IS MEDICALLY ADVISABLE, THE PRODUCT LITERATURE FOR THAT AGENT SHOULD BE CONSULTED FOR COMPLETE PRESCRIBING INFORMATION. |