VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0)
FDA premarket approval P840068/S031 · decided 1997-03-25
Approval details
- PMA number
- P840068
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1997-01-17
- Decision date
- 1997-03-25
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VIGOR MODEL 2880 SOFTWARE APPLICATION VERSION 3.0, TO BE USED WITH MODEL 2950 OR MODEL 2901 PROGRAMMER/RECORDER/MONITOR 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.