Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs)
FDA premarket approval P960040/S368 · decided 2016-04-14
Approval details
- PMA number
- P960040
- Supplement
- S368
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-03-23
- Decision date
- 2016-04-14
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors.
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