RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND

FDA premarket approval P950022/S041 · decided 2007-10-16

Approval details

PMA number

P950022

Supplement

S041

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2007-08-22

Decision date

2007-10-16

Days to decision

55 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL TO MODIFY THE SHOCK COIL ON THE RIATA ST OPTIM AND RIATA STS OPTIM LEADS AND TO ADD TWO NEW PASSIVE LEAD MODELS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA ST OPTIM LEAD MODELS 7020, 7021, 7022, 7030, 7031, 7070 AND 7071 AND RIATA STS OPTIM LEAD MODELS 7120, 7121,7122, 7130, 7131, 7170 AND 7171 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUL FOR SYSTEM INDICATIONS). THEY PROVIDE PACING AND SENSING AND DEL

510(k) clearances by this applicant