A209 SICD Gen 2, A219 SICD MRI
FDA premarket approval P110042/S196 · decided 2024-05-29
Approval details
- PMA number
- P110042
- Supplement
- S196
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- A209 SICD Gen 2, A219 SICD MRI
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-05-17
- Decision date
- 2024-05-29
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to add an alternate Sterile Pack Automation system at the Boston Scientific Clonmel manufacturing site
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