Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's.
FDA premarket approval P960040/S390 · decided 2017-05-18
Approval details
- PMA number
- P960040
- Supplement
- S390
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's.
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-03-06
- Decision date
- 2017-05-18
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for addition of alternate bondply adhesive suppliers for pulse generator Super Output Module (SOM) and High Voltage Charge (HVC) module substrates.
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