VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
FDA premarket approval P910077/S022 · decided 1998-01-23
Approval details
- PMA number
- P910077
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1997-07-28
- Decision date
- 1998-01-23
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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