PMA P810046S227

Device: SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S227
Product code: MAF
Decision date: 2008-12-10
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.

Current openFDA PMA Record#

Device: SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S227
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2008-12-10
Decision code: OK30
Date received: 2008-11-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.