ORIGEN EL ICD D050, D051, D052, D053; ORIGEN MINI ICD D000, D001, D002, D003; DYNAGEN EL ICD D150, D151, D152, D15
FDA premarket approval P960040/S366 · decided 2016-03-23
Approval details
- PMA number
- P960040
- Supplement
- S366
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN EL ICD D050, D051, D052, D053; ORIGEN MINI ICD D000, D001, D002, D003; DYNAGEN EL ICD D150, D151, D152, D15
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-02-29
- Decision date
- 2016-03-23
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Alternate supplier for the battery cathode tab insulator top/bottom.
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