GYNECARE INTERGEL ADHESION PREVENTION SOLUTION
FDA premarket approval P990015/S002 · decided 2003-03-18
Approval details
- PMA number
- P990015
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GYNECARE INTERGEL ADHESION PREVENTION SOLUTION
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Lifecore Biomedical, Inc.
- Date received
- 2002-09-19
- Decision date
- 2003-03-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- APPROVAL FOR CHANGES TO THE LABELING IN RESPONSE TO ADVERSE EVENT REPORTS OF ADDITIONAL SURGERY, INCLUDING HYSTERECTOMY, THAT OCCURRED FOLLOWING POST-OPERATIVE PAIN, ASCITES, NON-INFECTIOUS PERITONITIS, AND/OR POSSIBLE DELAYED CLEARANCE OF GYNECARE INTERGEL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (K073032) | Lifecore Biomedical, Inc. | 2007-11-16 |
| PRIMACONNEX CAD/CAM ABUTMENT SYSTEM (K072241) | Lifecore Biomedical, Inc. | 2007-11-09 |
| RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS (K072768) | Lifecore Biomedical, Inc. | 2007-10-23 |
| PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS (K072572) | Lifecore Biomedical, Inc. | 2007-10-05 |
| PRIMACONNEX CERAMIC ABUTMENTS (K062876) | Lifecore Biomedical, Inc. | 2006-11-01 |
| SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. (K060530) | Lifecore Biomedical, Inc. | 2006-05-22 |
| STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 (K053643) | Lifecore Biomedical, Inc. | 2006-01-23 |
| PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS (K051614) | Lifecore Biomedical, Inc. | 2005-09-09 |