DYNAGEN EL ICD: D150, D151, D152, D153; INOGEN EL ICD: D140, D141, D142, D143; ORIGEN EL ICD: D050, D051, D052, D053;
FDA premarket approval P960040/S378 · decided 2016-08-01
Approval details
- PMA number
- P960040
- Supplement
- S378
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN EL ICD: D150, D151, D152, D153; INOGEN EL ICD: D140, D141, D142, D143; ORIGEN EL ICD: D050, D051, D052, D053;
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-07-07
- Decision date
- 2016-08-01
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Alternate supplier of the titanium raw material used for capacitor can manufacturing.
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