DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
FDA premarket approval P960040/S335 · decided 2014-10-28
Approval details
- PMA number
- P960040
- Supplement
- S335
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-10-03
- Decision date
- 2014-10-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE SUPPLIERS MANUFACTURING PROCESS FOR THE BACKFILL HOLE IN THE HIGH VOLTAGE CAPACITOR CANS (HV CAP).
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