IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN,
FDA premarket approval P960040/S363 · decided 2016-03-03
Approval details
- PMA number
- P960040
- Supplement
- S363
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-01-20
- Decision date
- 2016-03-03
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for updates to the Physicians Technical Manuals for ICDs and CRT-Ds
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