PMA P040050S007

Device: MACROPLASTIQUE IMPLANTS
Applicant: Uroplasty, LLC
PMA number: P040050
Supplement: S007
Product code: LNM
Decision date: 2011-02-04
Classification: Agent, Bulking, Injectable For Gastro-urology Use
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: APPROVAL FOR A CONTRACT GAMMA STERILIZATION SITE LOCATED AT STERIS/ISOMEDIX CONTRACT STERILIZATION SERVICES, LIBERTYVILLE, ILLINOIS.

Current openFDA PMA Record#

Device: MACROPLASTIQUE IMPLANTS
Applicant: Uroplasty, LLC
PMA number: P040050
Supplement: S007
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2011-02-04
Decision code: APPR
Date received: 2010-11-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CONTRACT GAMMA STERILIZATION SITE LOCATED AT STERIS/ISOMEDIX CONTRACT STERILIZATION SERVICES, LIBERTYVILLE, ILLINOIS.