PMA P830061S028

Device: MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S028
Product code: DTB
Decision date: 1998-08-12
Classification: Permanent Pacemaker Electrode
Generic name: permanent pacemaker Electrode
Approval order statement: Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.

Current openFDA PMA Record#

Device: MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S028
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 1998-08-12
Decision code: APPR
Date received: 1998-04-20
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.