LATITUDE G2 COMMUNICATOR
FDA premarket approval P910077/S127 · decided 2012-11-07
Approval details
- PMA number
- P910077
- Supplement
- S127
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LATITUDE G2 COMMUNICATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-10-12
- Decision date
- 2012-11-07
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ALTERNATE SURFACE MOUNT TECHNOLOGY MANUFACTURING LINE AT THE CONTRACT MANUFACTURER.
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