PMA P870056S060

Device: CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT
Applicant: Edwards Lifesciences, LLC
PMA number: P870056
Supplement: S060
Product code: DYE
Decision date: 2013-07-16
Generic name: replacement Heart-valve
Approval order statement: REMOVAL OF A BIOLOGICAL INDICATOR REQUIREMENT FROM THE STERILIZATION CONVENTIONAL RELEASE PROGRAM TO ALIGN WITH THE LATEST VERSION OF THE ISO 14160 (2011) FOR LIQUID CHEMICAL STERILIZATION.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT
Applicant: Edwards Lifesciences, LLC
PMA number: P870056
Supplement: S060
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2013-07-16
Decision code: OK30
Date received: 2013-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REMOVAL OF A BIOLOGICAL INDICATOR REQUIREMENT FROM THE STERILIZATION CONVENTIONAL RELEASE PROGRAM TO ALIGN WITH THE LATEST VERSION OF THE ISO 14160 (2011) FOR LIQUID CHEMICAL STERILIZATION.