CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
FDA premarket approval P110042/S032 · decided 2014-04-28
Approval details
- PMA number
- P110042
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-04-14
- Decision date
- 2014-04-28
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- BOSTON SCIENTIFIC CORPORATION (BSC) TO BE THE SECOND SUPPLIER FOR THEMANUFACTURE PROCESS OF THE HIGH VOLTAGE CAPACITOR LIDS TO BE USED IN THE DEVICE.
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