PMA P030009S072

Device: INTEGRITY RX CORONARY STENT SYSTEM; INTEGRITY OTW CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S072
Product code: MAF
Decision date: 2013-12-19
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.

Current openFDA PMA Record#

Device: INTEGRITY RX CORONARY STENT SYSTEM; INTEGRITY OTW CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P030009
Supplement: S072
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2013-12-19
Decision code: OK30
Date received: 2013-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.