TELIGEN/INCEPTA/ENERGEN/PUNCTUA ICDS
FDA premarket approval P960040/S249 · decided 2012-01-25
Approval details
- PMA number
- P960040
- Supplement
- S249
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELIGEN/INCEPTA/ENERGEN/PUNCTUA ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2011-12-28
- Decision date
- 2012-01-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- MANUFACTURE OF THE BATTERY COMPONENT TO BE MANUFACTURED INTERNALLY AT ITS BOSTON SCIENTIFIC ST. PAUL MANUFACTURING FACILITY.
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