DYNAGEN ICD Models D150, D151, D152, D153; INOGEN ICD Models D140,
FDA premarket approval P960040/S361 · decided 2016-03-28
Approval details
- PMA number
- P960040
- Supplement
- S361
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN ICD Models D150, D151, D152, D153; INOGEN ICD Models D140,
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-11-13
- Decision date
- 2016-03-28
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a modification to the charge time ratio limit for the high voltage capacitor.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.