INTERGEL ADHESION PREVENTION SOLUTION

FDA premarket approval P990015 · decided 2001-11-16

Approval details

PMA number: P990015
Trade name: INTERGEL ADHESION PREVENTION SOLUTION
Generic name: Barrier, absorbable, adhesion
Applicant: Lifecore Biomedical, Inc.
Date received: 1999-03-08
Decision date: 2001-11-16
Days to decision: 984 days
Decision code: APWD
Product code: MCN
Advisory committee: Obstetrics/Gynecology
Expedited review: Yes
Location: Chaska, MN
Statement: APPROVAL FOR THE GYNECARE INTERGEL ADHESION PREVENTIION SOLUTION. THE DEVICE IS INDICATED FOR USE IN PATIENTS UNDERGOING OPEN, CONSERVATIVE GYNECOLOGIC SURGERY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE TO REDUCE POST-SURGICAL ADHESIONS. GYNECARE INTERGEL ADHESION PREVENTION SOLUTION IS ALSO INTENDED TO REDUCE THE LIKELIHOOD OF DEVELOPING MODERATE OR SEVERE POSTOPERATIVE ADNEXAL ADHESIONS IN THESE PATIENTS.

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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