UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR
FDA premarket approval P910020/S012 · decided 1996-07-31
Approval details
- PMA number
- P910020
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1995-09-11
- Decision date
- 1996-07-31
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE UNITY MODEL 292-07 SINGLE PASS (VDDR) PULSE GENERATOR WITH UNIPASS LEADS MODELS 425-02, 425-04 AND 425-06 AND MODEL 531-60 GRAPHICS PROGRAM MODULE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UNITY
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