DYNAGEN, INOGEN, ORIGEN ICD DEVICES
FDA premarket approval P960040/S350 · decided 2015-07-31
Approval details
- PMA number
- P960040
- Supplement
- S350
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN, INOGEN, ORIGEN ICD DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-07-08
- Decision date
- 2015-07-31
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- MODIFY THE MINIMUM BURN-IN TIME FOR THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.