PMA P810046S218

Device: CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S218
Product code: MAF
Decision date: 2005-01-14
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: MANUFACTURING PROCESS CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).

Current openFDA PMA Record#

Device: CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S218
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2005-01-14
Decision code: OK30
Date received: 2004-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).