MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
FDA premarket approval P940031/S012 · decided 1998-03-27
Approval details
- PMA number
- P940031
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-03-04
- Decision date
- 1998-03-27
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.
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