VENTRITEX(R) TVL(R) LEAD SYSTEM
FDA premarket approval P950022/S009 · decided 2000-07-06
Approval details
- PMA number
- P950022
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTRITEX(R) TVL(R) LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-06-08
- Decision date
- 2000-07-06
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE TVL RIGHT VENTRICULAR (RV) LEAD MODELS RV06 AND RV07.
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