MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2)
FDA premarket approval P010012/S012 · decided 2003-07-02
Approval details
- PMA number
- P010012
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2003-04-24
- Decision date
- 2003-07-02
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION, VERSION 3.2.
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