PMA P930029S067

Device: RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II
Applicant: Medtronic, Inc.
PMA number: P930029
Supplement: S067
Product code: LPB
Decision date: 2020-09-25
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Add the incoming inspection testing for Metallographic Interpretation and Metallographic Sample Preparation (Cross Section) at the MPROC Juncos facility.

Current openFDA PMA Record#

Device: RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II
Applicant: Medtronic, Inc.
PMA number: P930029
Supplement: S067
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2020-09-25
Decision code: OK30
Date received: 2020-08-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add the incoming inspection testing for Metallographic Interpretation and Metallographic Sample Preparation (Cross Section) at the MPROC Juncos facility.