TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI, ORIGEN EL, ORIGEN MINI ICD'S
FDA premarket approval P960040/S351 · decided 2015-09-17
Approval details
- PMA number
- P960040
- Supplement
- S351
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI, ORIGEN EL, ORIGEN MINI ICD'S
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-07-13
- Decision date
- 2015-09-17
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO PULSE GENERATOR FIRMWARE AND PROGRAMMER SOFTWARE, FOR LABELING CHANGES ASSOCIATED WITH THE SOFTWARE UPDATES, AND FOR THE COMBINATION OF PHYSICIAN TECHNICAL MANUALS AND DEVICE REFERENCE GUIDES INTO ONE COMPREHENSIVE DOCUMENT ACROSS DEVICE FAMILIES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.