MODEL 2901 PROGRAMMERR SYSTEM
FDA premarket approval P940031/S005 · decided 1996-11-07
Approval details
- PMA number
- P940031
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2901 PROGRAMMERR SYSTEM
- Generic name
- Programmer, pacemaker
- Applicant
- Boston Scientific
- Date received
- 1996-03-25
- Decision date
- 1996-11-07
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR 1)A NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING COTRACT FACILIYT, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987
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