PUNCTUA ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161,
FDA premarket approval P960040/S252 · decided 2012-03-15
Approval details
- PMA number
- P960040
- Supplement
- S252
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PUNCTUA ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161,
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-02-09
- Decision date
- 2012-03-15
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES AND ASSOCIATED MANUFACTURING CHANGES TO THE PUNCTUA/ INCEPTA/ ENERGEN HYBRID ASSEMBLY.
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