PMA P010012S131

Device: CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S131
Product code: LWP
Decision date: 2006-08-25
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.

Current openFDA PMA Record#

Device: CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S131
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2006-08-25
Decision code: APPR
Date received: 2006-05-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.