ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS
FDA premarket approval P960040/S329 · decided 2014-09-04
Approval details
- PMA number
- P960040
- Supplement
- S329
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-08-14
- Decision date
- 2014-09-04
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN A QUALITY CONTROL INSPECTION TEST 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.