PMA P950022S028

Device: RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052
Applicant: ABBOTT MEDICAL
PMA number: P950022
Supplement: S028
Product code: LWS
Decision date: 2006-03-07
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: APPROVAL FOR: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL. 2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS. 3) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 TO CREATE A PASSIVE FIXATION AND A PASSIVE FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7040, 7041 AND 7042 (PASSIVE FIXATION) AND RIATA ST MODELS 7050, 7051, 7052 (PASSIVE FIXATION INTEGRATED BIPOLAR) AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.

Current openFDA PMA Record#

Device: RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052
Applicant: ABBOTT MEDICAL
PMA number: P950022
Supplement: S028
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2006-03-07
Decision code: APPR
Date received: 2006-02-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL. 2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS. 3) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 TO CREATE A PASSIVE FIXATION AND A PASSIVE FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7040, 7041 AND 7042 (PASSIVE FIXATION) AND RIATA ST MODELS 7050, 7051, 7052 (PASSIVE FIXATION INTEGRATED BIPOLAR) AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.