DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
FDA premarket approval P840068/S035 · decided 1998-05-28
Approval details
- PMA number
- P840068
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-05-07
- Decision date
- 1998-05-28
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.