RIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071
FDA premarket approval P950022/S030 · decided 2006-07-07
Approval details
- PMA number
- P950022
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-06-05
- Decision date
- 2006-07-07
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL TO PLACE AN OVERLAY OVER THE SILICONE LEAD BODY OF THE RIATA ST LEADS TO CREATE THE NEW RIATA ST OPTIM LEAD MODELS 7020, 7021, 7022, 7030, 7031, 7070 AND 7071 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
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