Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG
FDA premarket approval P960040/S422 · decided 2018-03-12
Approval details
- PMA number
- P960040
- Supplement
- S422
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-02-16
- Decision date
- 2018-03-12
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Alternate test method system for battery electrolyte inspection.
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