SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE (S-ICD) SYSTEM EMBLEM
FDA premarket approval P110042/S065 · decided 2016-10-13
Approval details
- PMA number
- P110042
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE (S-ICD) SYSTEM EMBLEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2016-09-16
- Decision date
- 2016-10-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Automate the process of applying medical adhesive to the battery feedthru assembly.
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