PMA P800012S009

Device: DRILAC CUBES AND GRANULES
Applicant: Osmed, Inc.
PMA number: P800012
Supplement: S009
Product code: LPG
Decision date: 2002-09-17
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement: APPROVAL FOR NEW MANUFACTURING AND STERILIZATION SITES. THE MANUFACTURING SITE IS LOCATED AT KENSEY NASH CORPORATION, EXTON, PA. THE NEW STERILIZATION SITE IS LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NJ.

Current openFDA PMA Record

Device: DRILAC CUBES AND GRANULES
Applicant: Osmed, Inc.
PMA number: P800012
Supplement: S009
Product code: LPG
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date: 2002-09-17
Decision code: APPR
Date received: 2002-08-12
Supplement type: Normal 180 Day Track
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR NEW MANUFACTURING AND STERILIZATION SITES. THE MANUFACTURING SITE IS LOCATED AT KENSEY NASH CORPORATION, EXTON, PA. THE NEW STERILIZATION SITE IS LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NJ.