DYNAGEN ICD, INOGEN ICD, ORIGEN ICD
FDA premarket approval P960040/S334 · decided 2014-10-20
Approval details
- PMA number
- P960040
- Supplement
- S334
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN ICD, INOGEN ICD, ORIGEN ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-09-29
- Decision date
- 2014-10-20
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- MANUFACTURE THE FEEDTHRU RIVETS OF THE HV CAPACITOR INTERNALLY FOR THE DEVICES RATHER THAN PURCHASING FROM A SUPPLIER.
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