TVL(TM) LEAD SYSTEM
FDA premarket approval P950022 · decided 1996-05-10
Approval details
- PMA number
- P950022
- Trade name
- TVL(TM) LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1995-06-30
- Decision date
- 1996-05-10
- Days to decision
- 315 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE VENTRITEX TVL LEAD SYSTEM:TRANSVENOUS RIGHT VENTRICULAR LEAD MODELS RV-1101, RV01, AND RV02; TRANSVENOUS SUPERIOR VENA CAVA LEAD MODELS, SV-1101, SV01, SV02, AND SV03; SUBCUTANEOUS LEAD MODELS, SQ-701 AND SQ01; VEIN PICK MODEL TV-0001; SILICONE LUBRICANT MODEL TV-0013; LEAD TUNNELER KIT MODEL LTK-01; MODEL AC-2481 HIGH VOLTAGE Y-ADAPTER; MODEL AC-CDT-EX VENTRITEX EXTERNAL STIMULATOR ADAPTER; AND TVL LEAD SYSTEM ACCESSORY KIT
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