VIGOR MODEL 2880 SOFTWARE APPLICATION
FDA premarket approval P840068/S029 · decided 1996-11-07
Approval details
- PMA number
- P840068
- Supplement
- S029
- 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
- 1996-03-25
- Decision date
- 1996-11-07
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- 1)NEW PROGRAMMING SYSTEM, WITH MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2)A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987
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