MODEL 2901 PROGRAMMER
FDA premarket approval P910077/S014 · decided 1996-11-07
Approval details
- PMA number
- P910077
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2901 PROGRAMMER
- 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 A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987
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