DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
FDA premarket approval P840068/S037 · decided 1998-08-26
Approval details
- PMA number
- P840068
- Supplement
- S037
- 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
- 1998-08-05
- Decision date
- 1998-08-26
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for minor changes to the pacemaker top (header) and minor labeling changes for the Vigor SSI, Model 460 and Vigor SR, Model 1130.
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