VIGOR SOFTWARE APPLICATION; VERSION 5.2
FDA premarket approval P840068/S041 · decided 2001-04-30
Approval details
- PMA number
- P840068
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR SOFTWARE APPLICATION; VERSION 5.2
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2001-04-06
- Decision date
- 2001-04-30
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VIGOR MODEL 2880 V5.2 SOFTWARE.
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