PMA P950022S040
- Device
- RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S040
- Product code
- LWS
- Decision date
- 2007-09-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR DISTAL TIP CHANGES TO THE RIATA ST OPTIM LEAD FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA STS OPTIM LEAD MODELS 7120, 7121, 7122, 7130 AND 7131, AND ARE INDICATED FOR USE AS TRANSVENOUS, STEROID ELUTING, RIGHT VENTRICULAR DUAL AND SINGLE DEFIBRILLATION COIL LEADS WITH COMPATIBLE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S040
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-09-06
- Decision code
- APPR
- Date received
- 2007-07-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DISTAL TIP CHANGES TO THE RIATA ST OPTIM LEAD FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA STS OPTIM LEAD MODELS 7120, 7121, 7122, 7130 AND 7131, AND ARE INDICATED FOR USE AS TRANSVENOUS, STEROID ELUTING, RIGHT VENTRICULAR DUAL AND SINGLE DEFIBRILLATION COIL LEADS WITH COMPATIBLE PULSE GENERATORS.