VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES
FDA premarket approval P830060/S067 · decided 2011-09-01
Approval details
- PMA number
- P830060
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2011-03-28
- Decision date
- 2011-09-01
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE TERMINAL TOOL (RENAMED EZ-4 CONNECTOR TOOL), DESIGN CHANGE TO THE LEAD AND TOOL PACKAGING, AND VARIOUS LABELING CHANGES.
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