PMA P910077S022
- Device
- VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S022
- Product code
- LWS
- Decision date
- 1998-01-23
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for higher shock energy for the VENTAK MINI HE, the downsized VENTAK MINI III, revisions to the VENTAK MINI Application Software-Model 2840, and labeling revisions ot indicate shock energy as joules "stored" and updating the indications for use.
Current openFDA PMA Record#
- Device
- VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S022
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1998-01-23
- Decision code
- APPR
- Date received
- 1997-07-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for higher shock energy for the VENTAK MINI HE, the downsized VENTAK MINI III, revisions to the VENTAK MINI Application Software-Model 2840, and labeling revisions ot indicate shock energy as joules "stored" and updating the indications for use.