Product code MFA
- Device name
- Device, Removal, Pacemaker Electrode, Percutaneous
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P960042S073 | GlideLight Laser Sheath | Spectranetics (Philips) | 2025-12-18 |
| P960042S072 | Spectranetics Laser Sheath (GlideLight/SLS) | Spectranetics (Philips) | 2024-09-05 |
| P960042S071 | Spectranetics Laser Sheath (SLS ll/GlideLight) | Spectranetics (Philips) | 2023-05-04 |
| P960042S070 | Glidelight Laser Sheath | Spectranetics (Philips) | 2021-09-02 |
| P960042S069 | SLS/GlideLight | Spectranetics (Philips) | 2020-05-06 |
| P960042S068 | Spectranetics Laser Sheaths SLS | Spectranetics (Philips) | 2019-10-21 |
| P960042S067 | SLS/GlideLight | Spectranetics (Philips) | 2019-10-07 |
| P960042S066 | Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath | Spectranetics (Philips) | 2019-06-28 |
| P960042S065 | Spectranetics Laser Sheaths SLS | Spectranetics (Philips) | 2018-11-16 |
| P960042S064 | Spectranetics Laser Sheaths SLS | Spectranetics (Philips) | 2018-10-15 |
| P960042S063 | SLS ll/GlideLight Catheters | Spectranetics (Philips) | 2018-08-14 |
| P960042S062 | SLS II/GlideLight catheters | Spectranetics (Philips) | 2018-06-28 |
| P960042S061 | SLS II/Glide Light Catheters | Spectranetics (Philips) | 2018-05-31 |
| P960042S060 | Spectranetics Laser Sheaths SLS (SLS ll/GlideLight) | Spectranetics (Philips) | 2018-05-08 |
| P960042S059 | Spectranetics Laser Sheath II (SLS II) GlideLight Catheters | Spectranetics (Philips) | 2017-07-31 |
| P960042S058 | SLS / GlideLight | Spectranetics (Philips) | 2017-07-18 |
| P960042S057 | Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath | Spectranetics (Philips) | 2017-05-10 |
| P960042S056 | ELCA and SLS/GlideLight Catheter | Spectranetics (Philips) | 2017-04-24 |
| P960042S055 | SLS II/GLIDELIGHT CATHETERS | Spectranetics (Philips) | 2017-01-05 |
| P960042S054 | SPECTRANETICS LASER SHEATHS | Spectranetics (Philips) | 2016-06-16 |
| P960042S053 | SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH | Spectranetics (Philips) | 2016-04-13 |
| P960042S052 | SLS II AND GLIDELIGHT LASER SHEATH KITS | Spectranetics (Philips) | 2015-12-03 |
| P960042S051 | SPECTRANETICS LASER SHEATHS (SLS) | Spectranetics (Philips) | 2015-01-08 |
| P960042S050 | SPECTRANETICS LASER SHEATH SLS | Spectranetics (Philips) | 2014-10-30 |
| P960042S049 | SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT) | Spectranetics (Philips) | 2014-10-09 |
| P960042S048 | SPECTRANETICS LASER SHEATHS (SLS) | Spectranetics (Philips) | 2014-04-17 |
| P960042S047 | SPECTRANETICS LASER SHEATHS SLS | Spectranetics (Philips) | 2014-01-14 |
| P960042S043 | SPECTRANETICS LASER SHEATH | Spectranetics (Philips) | 2013-06-14 |
| P960042S046 | SLS SPECTRANETICS LASER SHEATHS | Spectranetics (Philips) | 2013-02-28 |
| P960042S045 | SPECTRANETICS LASER SHEATHS SLS | Spectranetics (Philips) | 2012-12-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00813132020309 | SLS II Laser Sheath | Spectranetics Corporation | 2015-02-06 |
| M204500303AA0 | GlideLight™ | Spectranetics Corporation | 2015-02-06 |
| M204500302AA0 | GlideLight™ | Spectranetics Corporation | 2015-02-06 |
| M204500301AA0 | GlideLight™ | Spectranetics Corporation | 2015-02-06 |
| M204500013AA0 | SLS™II | Spectranetics Corporation | 2015-02-06 |
| M204500012AA0 | SLS™II | Spectranetics Corporation | 2015-02-06 |
| M204500001AA0 | SLS™II | Spectranetics Corporation | 2015-02-06 |
| 00813132020347 | GlideLight Laser Sheath | Spectranetics Corporation | 2015-02-06 |
| 00813132020330 | GlideLight Laser Sheath | Spectranetics Corporation | 2015-02-06 |
| 00813132020323 | GlideLight Laser Sheath | Spectranetics Corporation | 2015-02-06 |
| 00813132020316 | SLS II Laser Sheath | Spectranetics Corporation | 2015-02-06 |
| 00813132020293 | SLS II Laser Sheath | Spectranetics Corporation | 2015-02-06 |
| M2045000120 | SLS™II | Spectranetics Corporation | 2014-08-19 |
| M2045000130 | SLS™II | Spectranetics Corporation | 2014-08-19 |
| M2045003010 | GlideLight™ | Spectranetics Corporation | 2014-08-19 |
| M2045003020 | GlideLight™ | Spectranetics Corporation | 2014-08-19 |
| M2045003030 | GlideLight™ | Spectranetics Corporation | 2014-08-19 |
| M2045000010 | SLS™II | Spectranetics Corporation | 2014-08-19 |