MODEL 2844 APPLICATION SOFTWARE, VERSION 3.5
FDA premarket approval P960040/S027 · decided 2002-10-07
Approval details
- PMA number
- P960040
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2844 APPLICATION SOFTWARE, VERSION 3.5
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2002-08-01
- Decision date
- 2002-10-07
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODEL 2844 SOFTWARE, VERSION 3.5.
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