TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P960040/S247 · decided 2012-01-13
Approval details
- PMA number
- P960040
- Supplement
- S247
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2011-12-14
- Decision date
- 2012-01-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- USE OF A NEW CATHODE MATERIAL IN THE HIGH VOLTAGE CAPACITOR AND A NEW SUPPLIER.
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