ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers
FDA premarket approval P150012/S002 · decided 2016-05-31
Approval details
- PMA number
- P150012
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-05-02
- Decision date
- 2016-05-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implementation of the following previously accepted manufacturing changes: 1) Removal of a plating process on the crystal oscillator component; 2) modifications to the crystal oscillator manufacturing process; 3) addition of an alternate supplier of a battery raw material; 4) addition of an alternate supplier of the power conductor component; 5) addition of an alternate supplier of the telemetry coils; 6) addition of an alternate supplier of capacitors; 7) addition of an automated visual inspect
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