ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN
FDA premarket approval P960040/S455 · decided 2020-10-22
Approval details
- PMA number
- P960040
- Supplement
- S455
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-10-01
- Decision date
- 2020-10-22
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.
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