MODELS 925, 2040, 2041, 6564
FDA premarket approval P840068/S004 · decided 1988-04-12
Approval details
- PMA number
- P840068
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODELS 925, 2040, 2041, 6564
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1987-10-06
- Decision date
- 1988-04-12
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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