MODEL 2844 VERSION 3.8
FDA premarket approval P960040/S047 · decided 2004-10-29
Approval details
- PMA number
- P960040
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2844 VERSION 3.8
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-10-05
- Decision date
- 2004-10-29
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE PROGRAMMER'S APPLICATION SOFTWARE MODEL 2844 VERSION 3.8.
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