VIGOR MODEL 2880 SOFTWARE APPLICATION
FDA premarket approval P840068/S028 · decided 1996-03-22
Approval details
- PMA number
- P840068
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR MODEL 2880 SOFTWARE APPLICATION
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-09-11
- Decision date
- 1996-03-22
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGOR PACEMAKERS
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