Dynagen Models D150, D151, D152, D153; Inogen Models D140, D141, D142, D143; Origen Models D050, D051, D052, D053 ICD
FDA premarket approval P960040/S364 · decided 2016-03-09
Approval details
- PMA number
- P960040
- Supplement
- S364
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dynagen Models D150, D151, D152, D153; Inogen Models D140, D141, D142, D143; Origen Models D050, D051, D052, D053 ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-02-11
- Decision date
- 2016-03-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Vertical integration of the high voltage capacitor can.
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