NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV
FDA premarket approval P960040/S410 · decided 2017-12-11
Approval details
- PMA number
- P960040
- Supplement
- S410
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-11-13
- Decision date
- 2017-12-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.
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