- Device
- VENTAK(R) P MODEL 1600
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S011
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-02-20
- Decision code
- APPR
- Date received
- 1995-06-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE AICD MODEL, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE